Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008132398

FEI Number

3002807091

Entity Name

Sterigenics UK Limited

City/State/Country

Alfreton Derbyshire, GB

Establishment Address

Cotes Park Lane, Somercotes, Alfreton Derbyshire DE55 4NJ, GB

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Sotera Health LLC (Owner Number: 10029425)

Owner / Operator Contact Address

2015 Spring Road, Suite 650, Oak Brook, IL 60523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INTEGUSEAL 0.2 µm filter for priming cardiopulmonary bypass circuits with 3/8 Intersept Pre-Bypass Filter Link Yankauer Suction Set Easyflow Suction Set All Galaxy II codes Galaxy II Reddick Saye Screw Retractor Kit DTRAX Spinal System Galaxy II All Galaxy II codes Folders & Injectors, Intraocular Lens (IOL) Single Use Soft Tipped Disposable Injector, Model R-INJ-04 KA2210/25 KA2110/50 TRU-FIX Catheter Fixation Kit KA1224/50 KA2210/50 KA1154/25 KA2254/25 KA1124/100 KA2310W/25 KA2154/50 MTS003/100 KA2130/50 KA1124/25 Zip DS Dressing Shield Bandages KA1118/50 KA2211/25 KA1254/25 OPSITE, IV3000 Frame Delivery COVRSITE Plus OPSITE, IV3000 1-Hand Breg OPSITE, IV3000 1-Hand Ported OPSITE Post Op, IV 3000 OPSITE Flexigrid, IV3000 Standard Skin Fix OPSITE Flexigrid, IV3000 Ported Tape & Bandage, Adhesive - 004792,004793,004794,004795, 004796,002970,003008,003276, 004342,003175,004322,005121, 005001 Incise Film BAND-AID® Brand TOUGH STRIPS® Bandages TrialOn BAND-AID® Brand Flexible Fabric Bandages Tube Holder 100/case Tube Holder White Dressings (Breg) SureSeal Pressure Bandage Primapore CovRsite Monopolar single-use HF cable MID Labs Disposable Ophthalmic Cannulas SIdeFlo Backflush instrument 27+ Advanced DSP Backflush Blunt Advanced DSP Backflush Soft Tip, 20G Advanced DSP Backflush Blunt, 23G D.O.R.C. Cannula Advanced DSP Backflush Blunt, 20G Advanced DSP Backflush Blunt, 25G Advanced DSP Backflush Soft Tip, 23G 27+ Advanced DSP Backflush Soft Tip Advanced DSP Backflush Soft Tip, 25G Irrigation and Aspiration Cannula UltraFlow Bimanual I/A Disposable Set Textured UltraFlow Bimanual I/A Disposable Set Polished Alcon Microsurgical Instruments 3312040 DePuy CMW 1 Bone Cement 3322020 DePuy CMW 2 Bone Cement 3312020 DePuy CMW 1 Bone Cement 3332040 DePuy CMW 3 Bone Cement 3322040 DePuy CMW 2 Bone Cement DePuy CMW 1 Bone Cement SmartSet MV Endurance Bone Cement 3332020 DePuy CMW 3 Bone Cement DePuy 3 CMW Bone Cement DePuy CMW 3 Bone Cement LIQUIBAND FLEX Irrigating Cystotome Disposable Cystotomes 60g SmartMix Cemvac prefilled with SmartSet HV Bone Cement, 80g SmartMix Cemvac prefilled with SmartSet HV Bone Cement, SmartMix Cemvac with SmartSet HV Bone Cement Infravision Universal Ureteral Kit IRIS Ureteral Kit ALLEVYN AG+ ALLEVYN Complete Care 3"x4" Primapad Non-Adherent Dressing 3"x8" Primapad Non-Adherent Dressing Biatain CUD Film Wound Dressing Silflex DUODERM STERILE DRESSING, DUODERM STERILE DRESSING (SIGNAL HYDROACTIVE), BORDER, CG, EXTRA THIN, 2"x3" Reliamed Non-Adherent Dressing Episil Absorbent DUODERM CGF BDR DRS 15X15CM (1X5PK) NAI DUODERM CGF DRS15X20CM (1X5PK) NAI DUODERM SIGNAL 20X20CM (1X5PK) NAI DUODERM SIGNAL 15X18CM (1X5PK) NAI DUODERM XTHIN DRS OVAL (1X20PK) NAI DUODERM CGF BDR DRS 10X10CM (1X5PK) NAI DUODERM CGF DRS 20X20CM (1X5PK) NAI DUODERM SIGNAL 20X22.5CM (1X5PK) NAI DUODERM SIGNAL 14X14CM (1X5PK) NAI DUODERM SIGNAL 20X23CM (1X5PK) NAI DUODERM XTHIN DRS TRG (1X10PK) NAI DUODERM SIGNAL 18.5X19.5CM (1X5PK) NAI Bolin Chest Seal DUODERM XTHIN DRS 10X10CM (1X10PK) NAI DUODERM CGF BDR DRS 6X6CM (1X5PK) NAI DUODERM CGF DRS 15X15CM (1X20PK) NAI DUODERM XTHIN DRS 5X20CM (1X10PK) NAI DUODERM XTHIN DRS OVAL (1X10PK) NAI DUODERM SIGNAL 11X19CM (1X5PK) NAI DUODERM XTHIN DRS 7.5X7.5CM (1X20PK) NAI DUODERM CGF DRS 15X15CM (1X5PK) NAI DUODERM CGF BDR DRS 10X13CM (1X5PK) NAI DUODERM CGF DRS 10X10CM (1X5PK) NAI DUODERM CGF DRS 20X30CM (1X5PK) NAI DUODERM CGF DRS 10X10CM (1X20PK) NAI DUODERM CGF BDR DRS 15X18CM (1X5PK) NAI DUODERM XTHIN DRS 5X10CM (1X20PK) NAI DUODERM SIGNAL 10X10CM (1X5PK) NAI DUODERM XTHIN DRS 15X15CM (1X10PK) NAI DUODERM DRS 10X10CM (1X20PK) NAI Biatain Silicone ALLEVYN Gentle Stratamed StrataXRT Biatain Silicone Lite Stratacel Allevyn Life H-Vent StrataGRT NelDerm Hydrogel Dressings Derpixa StrataCTX Comfeel Plus Biatain Super Non-Adhesive Band-Aid Neutrogena Sensitive Skin Triangle Acne Patches Comfeel Plus Contour Biatain Super Adhesive Adhesive Bandage Coverlet Biatain Silicone Non-border Neutrogena Sensitive Skin Mini Acne Patches Comfeel Plus Transparent Foam Lite ConvaTec Neutrogena Sensitive Skin Blemish Patches Episil Biatain Adhesive CUD+ CTD Dressing wound occlusive Biatain Soft-Hold 2"x3" Primapad Non-Adherent Dressing Biatain Non-Adhesive Neutrogena Sensitive Skin Nose Patches Hydrocolloid adhesive bandages Compeed Neutrogena Stubborn Acne Ultra-Thin Blemish Patches Biatain Silicone Fit LiDCOunity v2 Hemodynamic Monitoring System LiDCOunity v2 Monitor LiquiBand SPINAL NEEDLE 24G X 90MM (POUCH) 10/CA SINGLE SHOT (SDD) W/ DRUGS 10/CA EPIDURAL MINIPACK 17G WEISS + 10/CA C0NTINUOUS EPID (FL) W/O DRUGS 10/CA CSE (FL) W/O DRUGS 10/CA SPINAL(SDD) 22G WHITACRE W/DRUGS % 10/CA SINGLE SHOT (EDD) W/ DRUGS 10/CA SINGLE SHOT (SDD)W/O DRUGS +30/CA SPINAL(SHB)W/DRUGS 10/CA SPINAL (SDD) 27G WHITACRE W/DRUGS + 10/CA CONTINUOUS EPIDURAL (FL) W/DRUGS 10/CA *PhO*-CONTINUOUS EPID (FL) W/O DRUGS + 10/CA SPINAL TRAY 22/25 (SDD)W/DRUGS + 10/CA Portex Regional Anesthesia Trays CSE TRAY (LHB) W/DRUGS 10/CA SPINAL (SHB) W/DRUGS & DRUG LABELS 10/CA SPINAL PP B (SHB) + 10/CA SPINAL (SDD) 22G WHITACRE W/DRUGS + 10/CA Portex Regional Anesthesia Trays EPIDURAL NEEDLE 17G TUOHY 10/CA REGIONAL ANESTHESIA (EDD) W/DRUGS 10/CA SINGLE SHOT EPIDURAL(EDD)W/DRUGS + 10/CA SPINAL (SDD) 24G EUROPEAN PENCIL POINT W/DRUGS 10/CA SINGLE SHOT EPID(FL)W/O DRUGS + 10/CA SPINAL(FL)WHITACRE W/DRUGS & DRUG LABELS % 10/CA SINGLE SHOT EPID (EDD) W/DRUGS % 10/CA FACET (EDD)W/DRUGS + 10/CA CONT EPID(EDD-NP)DRUGS + 10/CA SINGLE SHOT EPID(DD) W/O DRUGS + 10/CA *PhO*-SINGLE SHOT EPID (SDD) W/DRUGS + 10/CA SPINAL (SDD) W/DRGS + 10/CA SPINAL (SHB) W/DRUGS 10/CA SPINAL TRAY (SHB) W/O DRUGS 10/CA SINGLE SHOT EPIDURAL (EDD)22G GLS LOR 10/CA CONTINUOUS EPIDURAL (EDD) W/DRUGS OE LOR + 10/CA NERVE BLOCK (FL)W/O DRUGS + 10/CA *PhO*-CONTINUOUS EPID(FL)W/DRUGS + 10/CA SINGLE SHOT (SDD) W/DRUGS + 10/CA NERVE BLOCK(FL)W/O DRUGS % 10/CA SINGLE SHOT EPID (EDD)W/DRUGS + 10/CA SPINAL TRAY (SDD) NP W/DRUGS + 10/CA CONTINUOUS EPIDURAL (EDD-NP) W/DRUGS + 10/CA SPINAL (SDD) 25G W/DRUGS + 10/CA Portex Regional Anesthesia Trays Regional Tray (EDD) W/Drugs 10/CA SINGLE SHOT (FL) W/DRUGS + 10/CA EPIDURAL SINGLE SHOT (EDD) W/O DRUGS + 10/CA SPINAL (FL) W/O DRUGS 10/CA CONTINUOUS EDID( FL) W/ DRUGS 10/CA REG ANES MID-PACK 17G TUOHY 10/CA REGIONAL ANES (EDD)W/DRUGS + 10/CA SPINAL (SDD) W/O DRUGS (IOD) 30/CA SINGLE SHOT EPID (EDD) W/DRUGS & DRUG LABELS 10/CA SINGLE SHOT EPID(SDD) W/O DRUGS + 30/CA SPINAL (SDD) 25G W/DRUGS + 10/CA CONTINUOUS EPID(FL)W/DRUGS AND DRUG LABELS % 10/CA LUMBAR PUNCTURE(EDD)W/DRUGS + 10/CA SINGLE SHOT EPID (DD) W/DRUGS + 10/CA NERVE BLOCK (EDD)W/O DRUGS + 10/CA EPIDURAL NEEDLE 18G TUOHY CAL+ 10/CA *PhO*-SINGLE SHOT EPID (EDD) W/DRUGS + 10/CA *PhO*NERVE BLOCK(EDD)W/DRUGS + 10/CA NERVE BLOCK(FL)W/O DRUGS + 10/CA SADDLE BLOCK (SDD) 25G QUINCKE W/ DRUGS + 10/CA CONTINUOUS EPID(FL)W/DRUGS % 10/CA Portex Regional Anesthesia Trays REGIONAL ANESTHESIA (SDD) W/DRUGS + 10/CA SINGLE SHOT EPID(DD)W/DRUGS % 10/CA *PhO*-CONTINUOUS EPID (FL) W/O DRUGS % 10/CA NOVAPLUS CONTINUOUS EPID(EDD) W/DRUGS % 10/CA NERVE BLOCK (LHB) W/DRUGS & DRUG LABELS 10/CA CONTINUOUS EPID(FL)W/DRUGS CD 10/CA Portex Regional Anesthesia Trays CONTINUOUS EPIDURAL (SHB) W/DRGS & DRG LABEL 10/CA CONTINUOUS EPID(EDD)W/DRUGS % 10/CA SPINAL (SDD) W/DRUGS 10/CA SPINAL TRAY (SHB) W/DRUGS + 10/CA *PhO*-REGIONAL ANESTHESIA (EDD) W/DRUGS 10/CA CONTINUOUS EPID(EDD) W/ DRUGS + 10/CA SPINAL (FL) WHITACRE W/O DRUGS 10/CA SINGLE SHOT EPID (SDD) W/O DRUGS + 10/CA LUMBAR PUNCTURE (EDD) W/DRUGS 10/CA SPINAL (FL) W/DRUGS 10/CA SINGLE SHOT (SDD) W/O DRUGS (IOD) 10/CA NERVE BLOCK (SDD) W/DRUGS 10/CA CONTINUOUS EPID (FL)W/O DRUGS + 10/CA EPIDURAL MINIPACK 17G HUSTEAD+ 10/CA CSE (FL) W/DRUGS AND DRUG LABELS + 10/CA SINGLE SHOT (EDD) W/DRUGS & DRUG LABELS 10/CA *PhO*-SPINAL (SHB) W/O DRUGS 10/CA SPINAL PP (SHB) W/ DRUGS % 10/CA CONTINUOUS EPID TRAY (EDD) W/DRUGS 10/CA *PhO*-SPINAL (SDD) W/DRUGS + 10/CA Single Shot Epidural (EDD) w/Drugs 10/ca NERVE BLOCK (SDD) W/O DRUGS + 10/CA NOVAPLUS SPINAL (SHB) W/DRUGS + 10/CA SINGLE SHOT EPID (EDD) W/DRUGS & DRUG LABELS 10/CA CONTINUOUS EPID (FL) W/O DRUGS + 10/CA SPINAL TRAY ( SDD) W/ DRUGS 10/CA SINGLE SHOT (EDD) W/O DRUGS (IOD) & W/DRG LABEL 10/CA SINGLE SHOT EPID(DD)W/DRUGS % 10/CA SPINAL(DD)W/DRUGS % 10/CA SINGLE SHOT(FL)W/DRUGS + 10/CA SPINAL(FL)WHITACRE W/DRUGS + DRUG LABELS % 10/CA CSE(FL)W/DRUGS + 10/CA CERVICAL BLOCK (FL) W/DRUGS 10/CA CONTINUOUS EPID(DD)W/DRUGS % 10/CA SINGLE SHOT(SDD)W/O DRUGS + 30/CA SPINAL(SDD) 22/25G QUINCKE W/DRUGS % 10/CA SPINAL TRAY (SDD) W/DRUGS + 10/CA SINGLE SHOT (SDD) W/O DRUGS (IOD) W/ DRUG LABELS 30/CA SPINAL PREP TRAY (SHB) % 10/CA SPINAL(DD)W/O DRUGS + 10/CA SINGLE SHOT (EDD) W/DRUGS + 10/CA CONTINUOUS (EDD)W/DRUGS + 10/CA SPINAL TRAY (SDD) W/ DRUGS 10/CA SINGLE SHOT EPID(FL)W.DRUGS + 10/CA REG ANES (SDD) W/DRUGS % 10/CA SINGLE SHOT EPID (SDD) W/DRUGS % 10/CA SINGLE SHOT (EDD) W/DRGS 10/CA CONTINUOUS EPID (FL) W/O DRUGS 10/CA NERVE STIMULATION ASSIST TRAY + 10/CA Portex Regional Anesthesia Trays CONTINUOUS (FL)W/O DRUGS + 10/CA PERIPHERAL NERVE BLOCK SINGLE SHOT(DD) W/DRG 10/CA SPINAL (EDD) W/O DRUGS % 10/CA EPIDURAL NEEDLE 18G HUSTEAD + 10/CA SPINAL TRAY (SDD) 25G NP W/DRUGS + 10/CA Portex Regional Anesthesia Trays SPINAL(FL)W/DRUGS + 10/CA CAUDAL SINGLE SHOT EPIDURAL TRAY (FL) W/DRUGS + 10/CA NERVE BLOCK ( SHB) W/ DRUGS 10/CA CONTINUOUS EPID (EDD) W/DRUGS & DRUG LABELS 10/CA CONTINUOUS EPID (FL) W/O DRUGS 10/CA SPINAL TRAY (EDD) W/DRUGS CONTINUOUS EPID (EDD) W/DRUGS 10/CA SINGLE SHOT EPID(FL)W/DRUGS % 10/CA CONTINUOUS EPIDURAL (EDD) W/DRUGS PLS + 10/CA CONTINUOUS EPID (EDD) W/DRUGS 10/CA SINGLE SHOT EPID (EDD) W/DRUGS AND DRUG LABELS + 10/CA REGIONAL ANESTHESIA TRAY (EDD) W/DRUGS 10/CA SPINAL (SDD) W/DRUGS 10/CA NOVAPLUS SPINAL (SDD) 25G W/DRUGS + 10/CA SINGLE SHOT(SHB)W/DRUGS + 10/CA SPINAL ( FL ) W/O DRUGS 10/CA SINGLE SHOT (FL) W/O DRUGS (IOD) 10/CA NERVE BLOCK W/O DRUGS (IOD) W/DRUG LABELS 30/CA SINGLE SHOT ( EDD) W/ DRUGS 10/CA SINGLE SHOT ( SDD) W/DRUGS 30/CA SPINAL TRAY (SHB)W/DRUGS + 10/CA LUMBAR PUNCTURE TRAY ( EDD) W/O DRUGS 10/CA SINGLE SHOT EPIDURAL (EDD) W/DRUGS 10/CA SADDLE BLOCK (SDD) 25G QUINCKE W/DRUGS + 10/CA Portex Regional Anesthesia Trays SPINAL(SDD) 22G WHITACRE W/ DRUGS % 10/CA CONTINUOUS EPID ( EDD ) W/DRUGS 10/CA SADDLE BLOCK (SDD) 25G QUINCKE W/ DRUGS % 10/CA FACET TRAY (EDD) W/DRUGS AND DRUG LABELS + 10/CA SPINAL(FL)W/DRUGS % 10/CA NERVE BLOCK TRAY (EDD) W/O DRUGS & DRUG LABELS 10/CA CONTINUOUS EPID(FL)W/DRUGS CD+ 10/CA *PhO*-SPINAL(DD)W/O DRUGS % 10/CA NERVE BLOCK(SDD)W/O DRUGS + 10/CA Portex Regional Anesthesia Trays TUOHY NEEDLE (POUCH) 20G X 6 SINGLE SHOT EPID (EDD) W/DRUGS % 10/CA Portex Regional Anesthesia Trays QUINCKE NEEDLE (POUCH) 22G X 4.5 SADDLE BLOCK (SDD) 26G W/DRUGS + 10/CA Portex Regional Anesthesia Trays REG ANES MID-PACK 17G TUOHY + 10/CA Portex Regional Anesthesia Trays CONTINUOUS EPID(EDD) W/DRUGS 10/CA Portex Regional Anesthesia Trays SADDLE BLOCK (SDD) 22G W/ DRUGS % 10/CA Portex Regional Anesthesia Trays SPINAL TRAY (SDD) NP W/DRUGS + 10/CA Portex Regional Anesthesia Trays SPINAL(SDD) 25G WHITACRE W/DRUGS % 10/CA Portex Regional Anesthesia Trays SADDLE BLOCK (SDD) 22G W/DRUGS + 10/CA Portex Regional Anesthesia Trays *PhO*-CATHETER CONNECTOR 21G + 25/CA Portex Regional Anesthesia Trays SPINAL PP (SHB) W/ DRUGS + 10/CA Portex Regional Anesthesia Trays CATH/CONN (CE) DURAFLEX + 10/CA Portex Regional Anesthesia Trays SPINAL (SDD)24G W/DRUGS + 10/CA Portex Regional Anesthesia Trays QUINCKE NEEDLE (POUCH) 22G X 5.5 SPINAL(SDD) 24G W/DRUGS % 10/CA Portex Regional Anesthesia Trays K965017 SPINAL (SDD)25G W/DRUGS + 10/CA Portex Regional Anesthesia Trays SADDLE BLOCK (SDD)25G W/DRUGS + 10/CA Portex Regional Anesthesia Trays REG ANES (SDD) W/DRUGS % 10/CA Portex Regional Anesthesia Trays DURAFLEX PLUS 19G MULTIPORT EPIDURAL CATHETER + 10/CA Portex Regional Anesthesia Trays SADDLE BLOCK (SDD) 25G QUINCKE W/DRUGS % 10/CA Portex Regional Anesthesia Trays *PhO*-CATHETER CONNECTOR 20G + 25/CA Portex Regional Anesthesia Trays SPINAL(SDD) 27G QUINCKE W/DRUGS % 10/CA Portex Regional Anesthesia Trays NEEDLE TUOHY 20G X 4.5 *PhO*EPID CATH DFXPLUS W/LOCKING CONN + 10/CA Portex Regional Anesthesia Trays SPINAL PP (SDD) 25G W/DRUGS + 10/CA Portex Regional Anesthesia Trays DURAFLEX PLUS 19G OPEN-ENDED EPIDURAL CATHETER + 10/CA Portex Regional Anesthesia Trays CONT EPID(EDD)18G TUOHY (DRG) 5ML G/LL LOR + 10/CA Portex Regional Anesthesia Trays SPINAL (SDD) 27G WHITACRE W/DRUGS + 10/CA Portex Regional Anesthesia Trays SPINAL(SDD) 22G WHITACRE W/DRUGS % 10/CA Portex Regional Anesthesia Trays CONTINUOUS EPID(FL)W/DRUGS CD+ 10/CA Portex Regional Anesthesia Trays SADDLE BLOCK 26G (SDD) W/DRUGS % 10/CA Portex Regional Anesthesia Trays SINGLE SHOT(EDD) W/ DRUGS 10/CA NERVE BLOCK W/DRUGS (SDD) + 10/CA SINGLE SHOT (FL) W/O DRUGS + 10/CA CONTINUOUS (EDD)W/DRUGS+10/CA SINGLE SHOT (DD) W/ DRUGS 10/CA SINGLE SHOT EPID (FL) W/O DRUGS (DR139) + 10/CA REGIONAL ANESTHESIA PREP TRAY + 10/CA CONTINUOUS EPID (LHB) W/DRUGS 10/CA *PhO*-NERVE BLOCK (EDD) W/DRUGS + 10/CA CONTINUOUS EPID(EDD)DURAFLEX PLUS 0E GLS LOR + 10/CA SPINAL (SDD)24G W/DRUGS + 10/CA SINGLE SHOT EPID(SDD)W/O DRUGS + 10/CA SPINAL (SDD)W/O DRUGS + 10/CA REGIONAL BLOCK (SHB) W/O DRUGS(10D) + 10/CA SPINAL(SDD)W/DRUGS 10/CA CONTINUOUS EPIDURAL (EDD) W/DRUGS + 10/CA CONTINUOUS EPID(FL)W/DRUGS % 10/CA SINGLE SHOT EPID (EDD) W/DRUGS + 10/CA SINGLE SHOT (SDD) W/O DRUGS + 30/CA EPIDURAL SINGLE SHOT(EDD)W/O DRUGS + 10/CA SINGLE SHOT EPID (EDD) W/DRUGS + 10/CA PROCEDRUAL TRAY (SDD) W/DRUGS 10/CA SINGLE SHOT (DD) W/DRUGS 24/CA SPINAL (SHB) W/DRUGS 10/CA SINGLE SHOT EPID(SHB)W/DRUGS + 10/CA CATH/CONN (CE) 10/CA CONTINUOUS EPID (EDD) W/DRUGS % 10/CA NERVE BLOCK (EDD) W/ DRUG LABELS 10/CA CONTINUOUS EPID ( EDD) W/DRUGS 10/CA NERVE BLOCK(SDD) W/DRUGS+10/CA CAUDAL EPID PEDI(FL)W/DRUGS % 10/CA SINGLE SHOT (SHB) W/DRUGS 10/CA SPINAL TRAY W/DRUGS ( SDD) & DRUG LABELS 10/CA SINGLE SHOT EPID (EDD) W/DRUGS 10/CA SINGLE SHOT (FL) W/DRUGS AND DRUG LABEL 10/CA SINGLE SHOT(EDD)W/DRUGS + 10/CA *PhO*-SINGLE SHOT EPID(FL)W/DRUGS % 10/CA EPIDURAL MINIPACK 18G TUOHY 10/CA *PhO*-NERVE BLOCK(SDD)W/DRUGS + 10/CA SPINAL TRAY (EDD) W/DRUGS + 10/CA SINGLE SHOT (EDD) 17G TUOHY W/DRUGS 10/CA NERVE BLOCK (FL) W/O DRUGS + 10/CA SPINAL (EDD)W/DRUGS AND DRUG LABELS + 10/CA CSE TRAY ( EDD ) W/ DRUGS 10/CA CONTINUOUS EPID(FL) W/DRUGS + 10/CA SPINAL TRAY (SDD)W/O DRUGS + 10/CA SINGLE SHOT EPID(EDD)W/DRUGS % 10/CA NERVE BLOCK (SHB) W/DRUGS + 10/CA LUMBAR PUNCTURE ( EDD) W/ DRUGS 10/CA EPIDURAL MINIPACK 18G TUOHY + 10/CA SINGLE SHOT EPID(EDD)W/ DRUGS + 10/CA SPINAL (SDD) W/DRUGS 10/CA LUMBAR TRAY ( EDD) W/ DRUGS 10/CA CONTINUOUS EPIDURAL (SDD) W/DRUGS & DRUG LABELS 10/CA SINGLE SHOT EPID (FL) W/DRUGS+ DRUG LABELS+ 10/CA SINGLE SHOT (SDD) W/O DRUGS + 10/CA CONTINUOUS EPID (EDD) W/DRUGS + 10/CA PREP(SHB)W/O DRUGS + 10/CA SPINAL TRAY(SDD)W/DRUGS +10/CA REG ANES MINIPACK W/MP DURAFLEX + 10/CA CONTINUOUS EPID (DD) W/DRUGS +10/CA SINGLE SHOT EPID(FL)W/DRUGS % 10/CA NERVE BLOCK(FL)W/DRUGS + 10/CA NERVE BLOCK (SDD)W/O DRUGS + 10/CA SPINAL(DD)WHITACRE W/O DRUGS + 10/CA SPINAL TRAY (FL) W/O DRUGS 10/CA SINGLE SHOT (SHB) W/O DRUGS 10/CA EPIDURAL MINIPACK 17G HUSTEAD + 10/CA SPINAL (FL) W/O DRUGS + 10/CA *PhO*-SINGLE SHOT EPID (EDD) W/DRUGS 10/CA SPINAL TRAY 22/25 (SDD) W/DRUGS + 10/CA CONTINUOUS EPID(EDD) W/DRUGS AND DRUG LABELS+ 10/CA SADDLE BLOCK( SDD) W/ DRUGS 10/CA SINGLE SHOT EPIDURAL (EDD) 20G GLL + 10/CA CONTINUOUS EPID (EDD)W/DRUGS 10/CA NERVE BLOCK (EDD) W/DRUGS + 10/CA SINGLE SHOT(DD)W/DRUGS + 10/CA UNIVERSAL EPIDURAL (SHB) W/O DRUGS + 10/CA NERVE BLOCK TRAY (EDD) W/DRUGS 10/CA SPINAL (SHB) W/DRUGS AND DRUG LABELS + 10/CA LUMBAR PUNCTURE,ADULT(EDD) W/DRUGS + 10/CA SPINAL(SHB)WHITACRE W/DRUGS % 10/CA SPINAL TRAY (SDD) W/DRUGS 10/CA CSE EPID ANES TRAY (EDD) W/DRUGS 10/CA NERVE BLOCK (EDD) W/ DRUGS 10/CA CONTINUOUS W/DRUGS (EDD) 10/CA SPINAL (EDD)W/DRUGS 10/CA CONTINUOUS EPID (FL) W/O DRUGS 10/CA NOVAPLUS CONTINUOUS EPIDURAL (EDD) W/DRUGS GLS LOR + 10/CA SPINAL (SDD)25G W/DRUGS + 10/CA NERVE BLOCK (SDD) W/DRUGS + 10/CA NERVE BLOCK (SDD) W/O DRUGS (IOD) + 30/CA LUMBAR PUNCTURE (EDD) W/O DRG 10/CA SPINAL TRAY W/DRUGS(SDD) + 10/CA NERVE BLOCK ( SDD) W/O DRUGS (IOD) 30/CA SINGLE SHOT (EDD) W/DRUG 10/CA CONTINUOUS EPID (EDD) W/DRUGS AND DRUG LABELS + 10/CA CSE TRAY (EDD)+10/CA SINGLE SHOT (SDD) W/DRUGS 30/CA NERVE BLOCK (EDD) W/DRUGS 10/CA SINGLE SHOT (EDD) W/DRUGS 10/CA SPINAL TRAY (SDD)W/DRUGS + 10/CA NERVE BLOCK(DD)W/DRUGS + 10/CA SINGLE SHOT EPID (EDD) W/DRUGS 10/CA SINGLE SHOT(FL)W/O DRUGS + 10/CA CONTINUOUS (FL) W/DRUGS + 10/CA NERVE BLOCK (EDD) W/O DRUGS 10/CA CSE(FL)W/DRUGS 10/CA NERVE BLOCK ( SDD) W/O DRUGS (IOD) W/DRUG LABEL 30/CA SINGLE SHOT EPID (EDD) W/DRUGS % 10/CA CONTINUOUS EPID(EDD)W/DRUGS 10/CA CONTINUOUS EPID (EDD) 17G TUOHY W/DRUGS 10/CA NERVE BLOCK (EDD) W/DRUGS AND DRUG LABELS 10/CA SINGLE SHOT EPID (FL)W/DRUGS 10/CA EPIDURAL SINGLE SHOT(SDD)W/DRUGS + 10/CA SINGLE SHOT (SDD) W/O DRUGS(IOD) + 10/CA SPINAL PP NP (SDD) W/ DRUGS + 10/CA CONTINUOUS EPID (EDD)W/O DRUGS + 10/CA SPINAL TRAY ( EDD) W/ DRUGS 10/CA OB SPINAL TRAY (SDD) W/DRUGS + 10/CA NERVE BLOCK (SDD) W/DRUGS & DRUG LABELS + 10/CA SPINAL PP (SDD) 25G W/DRUGS + 10/CA NERVE BLOCK (EDD) W/DRUGS AND DRUG LABELS 10/CA LUMBAR PUNCTURE ( EDD) W/ DRUGS 10/CA EPIDURAL SINGLE SHOT (EDD) W/DRUGS + 10/CA NERVE BLOCK (EDD) W/DRUGS 10/CA SPINAL (EDD) W/DRUGS AND DRUG LABELS + 10/CA SPINAL(FL)W/DRUGS & DRUG LABELS + 10/CA SPINAL ( SDD) W/DRUGS 10/CA SINGLE SHOT EPIDURAL (EDD)18G GLL LOR + 10/CA MYELOGRAM TRAY (EDD) 20G W/DRUGS + 10/CA NERVE BLOCK (EDD) W/ DRUGS 10/CA SINGLE SHOT EPID(DD)W/O DRUGS% 10/CA SINGLE SHOT (EDD) W/O DRUGS (IOD) & W/DRG LABEL 10/CA AMNIOCENTESIS (FL) W/DRUGS 10/CA SINGLE SHOT EPIDURAL W/O DRUGS 10/CA + (EDD) CONTINUOUS EPIDURAL(EDD)W/DRUGS + 10/CA CONTINUOUS EPID (FL) W/O DRUGS + 10/CA SINGLE SHOT EPID(FL)W/O DRUGS% 10/CA NERVE BLOCK (DD) W/O DRUGS + 24/CA EPIDURAL NEEDLE 20G TUOHY CAL+ 10/CA SPINAL(FL) W/DRUGS % 10/CA NERVE BLOCK(DD) W/DRUGS + 10/CA CONTINUOUS EPID(SDD)W/DRUGS + 10/CA SINGLE SHOT EPID(EDD)W/ODRUGS + 10/CA *PhO*-NERVE BLOCK (SDD) W/O DRUGS (IOD) 10/CA LUMBAR BLOCK(FL)W/DRUGS % 10/CA NERVE BLOCK (EDD) W/DRUGS 10/CA SINGLE SHOT EPID (EDD) W/DRUGS 10/CA REGIONAL ANES (EDD) W/DRUGS + 10/CA SPINAL(DD)WHITACRE W/DRUGS % 10/CA SPINAL(EDD)W/DRG % 10/CA SINGLE SHOT EPID (SHB) W/O DRUGS + 10/CA *PhO*-SINGLE SHOT EPID (EDD) W/DRUGS AND DRUG LABELS + 10/CA *PhO*-SPINAL(SHB)W/DRUGS + 10/CA LUMBAR TRAY ( EDD) W/O DRUGS 10/CA NERVE BLOCK (FL) W/DRUGS + 10/CA NOVAPLUS NERVE STIMULATION ASSIST TRAY + 10/CA PROCEDURAL W/DRUGS AND DRUG LABELS (SHB) + 10/CA SPINAL TRAY ( SDD) W/DRUGS 10/CA NERVE BLOCK ( EDD) W/DRUGS 10/CA EPIDURAL TRAY (SHB)W/DRUGS + DRUG LABELS 10/CA CONTINUOUS EPID (EDD) 18G HUSTEAD W/DRUGS 10/EA SINGLE SHOT EPID(SHB)W/DRUGS + 10/CA NERVE BLOCK (SDD) W/O DRUGS (IOD) W/ DRUG LABEL 30/CA SINGLE SHOT (FL)W/DRUGS + 10/CA SPINAL TRAY (FL ) W/O DRUGS 10/CA SINGLE SHOT (FL) W/ODRUGS + 10/CA CONTINUOUS EPID(EDD)W/DRUGS % 10/CA EPIDURAL NEEDLE 18G CRAWFORD(POUCH) 10/CA SPINAL TRAY(SDD)W/DRUGS + 10/CA SINGLE SHOT (SHB) W/DRUGS + 10/CA SINGLE SHOT (SDD)W/DRUGS 10/CA SINGLE SHOT (EDD) W/DRUGS + 10/CA SINGLE SHOT EPID (EDD) 18G TUOHY W/DRUGS 10/CA SPINAL(FL)W/O DRUGS + 10/CA REGIONAL ANESTHESIA TRAY (EDD) W/DRUGS + 10/CA CONTINUOUS EPIDURAL MINIPACK 10/CA SPINAL TRAY (SDD) 25G NP W/DRUGS + 10/CA CSE (FL) W/DRUGS 10/CA SINGLE SHOT EPIDURAL W/DRUGS (EDD) + 10/CA CONTINUOUS (FL) W/O DRUGS 10/CA CONTINUOUS EPID(FL)W/DRUGS % 10/CA SINGLE SHOT (SDD) W/O DRUGS (IOD) W/DRUG LABELS 30/CA NERVE BLOCK(SDD) W/O DRUGS (IOD) + 10/CA SINGLE SHOT (DD) W/DRUGS 24/CA SPINAL PP L (SHB) + 10/CA SPINAL TRAY ( SDD) W/DRUGS 10/CA PAIN CLINIC NERVE BLOCK TRAY(EDD)W/O DRG (IOD) 10/CA SINGLE SHOT EPID (EDD) W/ DRUGS 10/CA REGIONAL BLOCK TRAY (SDD) W/DRUGS + 10/CA NERVE BLOCK (SHB) W/O DRUGS 10/CA SPINAL EPP B (SHB) % 10/CA SPINAL TRAY (SDD) W/O DRUGS + 10/CA CONTINUOUS EPID(FL)W/O DRUGS + 10/CA *PhO*-SINGLE SHOT EPID(FL)W/DRUGS + 10/CA CATH/CONN(CE)POLYURETHANE RO + 10/CA *PhO*-EPID SINGLE SHOT (EDD) W/DRUGS AND DRUG LABELS + 10/CA SADDLE BLOCK (SDD) W/DRUGS + 10/CA CAUDAL (SDD)W/DRUGS +10/CA SINGLE SHOT EPID (SDD)W/DRUGS + 10/CA NERVE BLOCK (DD) W/DRUGS + 10/CA *PhO*-SINGLE SHOT EPID (FL) W/O DRUGS 10/CA SINGLE SHOT EPID (EDD) W/DRUGS AND DRUG LABELS 10/CA CONTINUOUS EPID(EDD)17G W/DRUGS,DURAFLEX + 10/CA *PhO*-CSE(EDD) W/DRUGS 10/CA SINGLE SHOT EPID (FL) W/O DRUGS + 10/CA SINGLE SHOT EPID(EDD)W/O DRUGS+ 10/CA NERVE BLOCK (EDD) W/DRUGS CHLORAPREP 10/CA CONTINUOUS EPID ( FL ) W/O DRUGS 10/CA SINGLE SHOT(EDD)W/DRUGS & DRUG LABELS 10/CA SPINAL (SDD) W/DRUGS 10/CA SINGLE SHOT (EDD) W/O DRUGS (W/DURAPREP) 10/CA SINGLE SHOT EP(EDD-NP)DRUGS + 10/CA *PhO*-SINGLE SHOT (SDD) W/DRUGS 10/CA SPINAL PP (SHB) % 10/CA PEDIATRIC CONTINUOUS EPIDURAL MINIPACK 18G TUOHY 10/CA SADDLE BLOCK (SDD) 22G W/ DRUGS + 10/CA SPINAL (SHB) W/DRUGS 10/CA SINGLE SHOT EPID(SDD)W/DRUGS + 10/CA SPINAL PP L (SHB) % 10/CA SPINAL(FL)WHITACRE W/O DRUGS % 10/CA CSE(FL)18G CSECURE,LOR PL 7ML,DRUGS + 10/CA SINGLE SHOT EPID(SHB)W/O DRGS+ 10/CA SPINAL PP B (SHB) % 10/CA Nerve Block (SDD) w/Drugs 10/CA SINGLE SHOT ( SDD ) W/O DRUGS 10/CA CONTINUOUS EPID (FL)W/DRUGS + 10/CA *PhO*-CONTINUOUS EPID (EDD)W/DRUGS 10/CA SADDLE BLOCK (SDD) 22G W/ DRUGS % 10/CA SINGLE SHOT (SDD) W/O DRUGS +30/CA PROCEDURAL W/DRUGS (SHB) + 10/CA SPINALPP B NP (SDD)W/DRGS + 10/CA SINGLE SHOT EPID(SHB) W/DRUGS AND DRUG LABELS 10/CA *PhO*SINGLE SHOT EPID(DD)W/O DRUGS+ 10/CA *PhO*-CONTINUOUS EPID(DD)W/DRUGS % 10/CA NOVAPLUS CONTINUOUS EPID(FL)W/DRUGS CD+ 10/CA CONTINUOUS EPID (FL) W/O DRUGS + 10/CA CONTINUOUS EPIDURAL (EDD-NP) W/O DRUGS + 10/CA *PhO*-SINGLE SHOT EPID (FL)W/O DRUGS + 10/CA *PhO*-SINGLE SHOT (FL) W/DRUGS 10/CA SINGLE SHOT EPID (FL) W/O DRUGS 10/CA CONTINUOUS EPIDURAL (EDD) W/DRUGS GLS LOR + 10/CA SPINAL(SDD) 25G WHITACRE W/DRUGS % 10/CA SINGLE SHOT (EDD)W/DRUGS 10/CA SPINAL(SDD) W/DRUGS 10/CA SINGLE SHOT (FL) W/O DRUGS 10/CA *PhO*-SINGLE SHOT EPID(SDD)W/O DRUGS + 10/CA SPINAL (SHB) W/DRUGS & DRUG LABELS 10/CA NERVE BLOCK (SDD) W/ DRUGS + 10/CA SPINAL (SDD) W/O DRUGS & DRUG LABELS + 10/CA REGIONAL ANESTHESIA (EDD) W/DRUGS + 10/CA EPIDURAL SINGLE SHOT (SDD) W/DRUGS + 10/CA SPINAL EPP (SHB) W/ DRUGS % 10/CA REGIONAL(EDD)W/DRUGS+10/CA REG ANES MID-PACK 18G TUOHY + 10/CA SPINAL(FL) W/DRUGS + 10/CA NERVE BLOCK (SHB) W/O DRUGS (IOD) W/DRUG LABEL 10/CA NERVE BLOCK(EDD)W/DRUGS + 10/CA CONTINUOUS EPID(FL)W/DRUGS AND DRUG LABELS + 10/CA SPINAL (FL) W/O DRUGS 10/CA CSE(EDD)W/DRUGS + 10/CA SINGLE SHOT (SDD) W/O DRUGS 30/CA EPIDURAL SINGLE SHOT(FL) W/DRUGS +10/CA SINGLE SHOT EPIDURAL (FL) W/DRUGS 10/CA SPINAL(SHB)W/DRUGS + 10/CA SPINAL PP B (SHB) CD% 10/CA SPINAL (SDD) W/DRUGS + 10/CA CSE (EDD) W/DRUGS 10/CA CONTINUOUS EPIDURAL (FL) W/O DRUGS 10/CA CONTINUOUS EPID (EDD) W/DRUGS 10/CA SPINAL(FL)WHITACRE W/O DRUGS % 10/CA SPINAL (SDD) 22/25G QUINCKE W/DRUGS 10/CA CONTINUOUS EPID (FL) W/O DRUGS (IOD) 10/EA SINGLE SHOT EPID(FL)W/O DRUGS + 10/CA CSE(EDD) W/DRUGS +10/CA SINGLE SHOT (FL) W/DRUGS 10/CA SPINAL TRAY ( SDD) W/DRUGS 10/CA SPINAL TRAY (SHB) W/ DRUGS 10/CA SINGLE SHOT ( SDD) W/O DRUGS (IOD) 30/CA PROCEDURAL TRAY (SDD) W/DRUGS + 10/CA SPINAL (EDD) W/DRUGS + 10/CA SINGLE SHOT EPID(EDD)W/ DRUGS % 10/CA CONTINUOUS EPID(FL)W/DRUGS % 10/CA SPINAL(DD)SPROTTE W/DRUGS % 10/CA *PhO*-SINGLE SHOT EPID(EDD)W/O DRUGS% 10/CA SINGLE SHOT (SDD)W/O DRUGS + 30/CA *PhO*-SPINAL TRAY (SHB) W/DRUGS 10/CA CSE (EDD) W/DRUGS + 10/CA SINGLE SHOT (EDD) W/DRUGS 10/CA *PhO*-CSE TRAY (FL) W/DRUGS 10/CA CONTINUOUS EPID(LHB)W/DRUGS % 10/CA SINGLE SHOT EPIDURAL (SHB) + 10/CA *PhO*-SINGLE SHOT EPID(SHB)W/DRUGS + 10/CA PROCEDURAL(SHB)W/DRUGS + 10/CA CONTINUOUS EPID (EDD) W/O DRUGS + 10/CA LUMBAR PUNCTURE ADULT NP (EDD) 10/CA SINGLE SHOT EPID(SHB) W/O DRUGS + 10/CA PROCEDURAL TRAY(SHB) W/DRUGS + 10/CA NERVE BLOCK(SDD)W/DRUGS + 10/CA CSE (EDD) W/ DRUGS 10/CA SPINAL (EDD)W/DRUGS + 10/CA EPIDURAL TRAY (EDD) W/DRUGS 10/CA CSE (FL) W/DRUGS + 10/CA SINGLE SHOT ( EDD) W/DRUGS 10/CA SINGLE SHOT EPIDURAL (EDD)18G PLS LOR + 10/CA SPINAL TRAY (SDD) W/DRUGS 10/CA SPINAL(DD)W/O DRUGS % 10/CA CONTINUOUS EPID(FL)W/O DRUGS 10/CA NERVE BLOCK (SDD) W/O DRUGS (IOD) + 10/CA SPINAL (SDD)25G W/ DRUGS + 10/CA CONTINUOUS EPIDURAL ( EDD) W/DRUGS 10CA NERVE BLOCK (EDD) W/DRUGS & DRUG LABELS 10/CA NERVE BLOCK(DD)W/DRUGS % 10/CA EPIDURAL NEEDLE 18G HUSTEAD 10/CA SINGLE SHOT EPID(SDD)W/DRUGS + 10/CA SINGLE SHOT EPID(FL)W/DRUGS + 10/CA NERVE BLOCK (SDD) W/O DRUGS (IOD) 30/CA SINGLE SHOT EPID (EDD) W/DRUGS 10/CA NERVE BLOCK (SDD) W/O DRUGS 10/CA *PhO*-SPINAL (FL) W/DRUGS + 10/CA 20 X 4 1/2 TUOHY W/WINGS + 10/CA NERVE BLOCK (SDD) W/O DRUGS + 30/CA CSE(FL)17G CSECURE,LOR PL 7ML,DRUGS + 10/CA SINGLE SHOT EPID (FL) W/DRUGS + 10/CA NERVE BLOCK(SHB)W/O DRUGS + 10/CA CONTINUOUS EPID (EDD) PEDIATRIC W/DRUGS 10/CA NERVE BLOCK(SDD) W/O DRUGS + 10/CA CSE (LHB) W/DRUGS + 10/CA NERVE BLOCK (SHB) W/DRUGS 10/CA SINGLE SHOT (FL) W/DRUGS 10/CA CONTINUOUS EPID (FL) W/O DRUGS 10/CA CONTINUOUS EPIDURAL (EDD) W/DRUGS GLL LOR 10/CA SPINAL EPP L (SHB) % 10/CA NERVE BLOCK (FL) W/DRUGS 10/CA NERVE BLOCK(SHB)W/DRUGS 10/CA EPIDURAL NEEDLE 17G TUOHY + 10/CA SPINAL(SDD)W/DRUGS + 10/CA SPINAL PP L NP (SDD) W/DRUGS + 10/CA CONTINUOUS EPID (EDD)W/DRUGS + 10/CA CONTINUOUS (EDD) W/DRUGS + 10/CA CONTINUOUS (EDD) W/DRUGS 10/CA NERVE BLOCK (SDD) W/O DRUGS (IOD) 10/CA SPINAL(FL)W/O DRUGS % 10/CA NOVAPLUS SINGLE SHOT EPID(EDD)W/DRUGS % 10/CA AMNIOCENTESIS (PB) W/O DRUGS (IOD) 10/CA SINGLE SHOT EPID (EDD) W/DRUGS 10/CA SPINAL TRAY ( SDD) W/ DRUGS 10/CA CONTINUOUS EPID(FL)HD W/DRUGS% 10/CA Portex Regional Anesthia Trays S.A.S.NERVE BLOCK(SDD)W/ODRUGS + 10/CA CSE TRAY (EDD) W/DRUGS + 10/CA REGIONAL ANESTHESIA PREP TRAY (EDD) W/DRUGS 10/CA SPINAL (FL) W/DRUGS + 10/CA CSE(FL)18G CSECURE,LOR GL 5ML,DRUGS + 10/CA NERVE BLOCK(EDD)W/DRUGS 10/CA SINGLE SHOT (EDD) W/ DRUGS 10/CA SPINAL (SDD) W/ DRUGS 10/CA SPINAL TRAY(EDD)W/DRUGS + 10/CA SINGLE SHOT (SDD)W/O DRUGS (IOD) W/DRUG LABEL +30/CA SPINAL (SDD)W/DRUGS + 10/CA EPIDURAL MINI PACK + 10/CA SINGLE SHOT EPID(FL)W/DRUGS + 10/CA UNIVERSAL(SHB)W/DRUGS & DRUG LABELS + 10/CA SINGLE SHOT EPID (SDD) W/DRUGS + 10/CA REGIONAL ANESTH (SDD) W/O DRUGS (IOD) + 30/CA NERVE BLOCK (SDD) W/O DRUGS, CHLORAPREP 10/CA NERVE BLOCK (LHB) W/O DRUGS 10/CA CONTINUOUS EPID (FL) W/O DRUGS + 10/CA SADDLE BLOCK 26G (SDD) W/ DRUGS % 10/CA SPINAL (FL) W/O DRUGS 10/CA NERVE BLOCK(EDD) W/DRUGS 10/CA *PhO*-SINGLE SHOT EPID (SDD) W/O DRUGS (IOD) 10/CA CONTINUOUS EPID(FL)W/DRUGS + 10/CA SPINAL (SHB) W/DRUGS + 10/CA LUMBAR PUNCTURE ADULT TRAY W/DRUGS (EDD) + 10/CA CONTINUOUS EPID(EDD)W/DRUGS AND DRUG LABELS 10/CA SPINAL(EDD)W/DRUGS + 10/CA NERVE BLOCK (SHB) W/O DRGS & DRG LABELS (IOD) 10/CA SPINAL(SHB)W/DRUGS % 10/CA PAIN CLINIC EPIDURAL TRAY(EDD)W/O DRG(IOD) 10/CA SINGLE SHOT EPID (DD) W/DRUGS 10/CA SINGLE SHOT EPID (FL) W/O DRUGS + 10/CA CSE ( EDD ) W/DRUGS 10/CA SPINAL(SDD)W/DRUGS 10/CA SINGLE SHOT (EDD) W/DRUGS & DRUG LABELS 10/CA NERVE BLOCK (SDD) W/DRUGS 10/CA SPINAL(SDD)25G WHITACRE W/DRUGS + 10/CA SPINAL (DD) W/O DRUGS 10/CA SADDLE BLOCK (SDD) 26G W/ DRUGS + 10/CA CONTINUOUS EPIDURAL (FL) W/DRUGS 10/CA PERIPHERAL NERVE BLOCK CATHETER INSERTION TRAY 10/CA ADULT CONTINUOUS EPIDURAL MINIPACK 18G TUOHY 10/CA CONTINUOUS(FL)W/O DRUGS + 10/CA LUMBAR TRAY ( EDD) W/O DRUGS 10/CA CONTINUOUS EPIDURAL 17G TUOHY (EDD) W/DRUGS 10/CA NERVE BLOCK ( SDD) W/O DRUGS (IOD) 30/CA SINGLE SHOT (EDD) W/O DRUGS (IOD) 10/CA CONTINUOUS EPIDURAL (EDD) W/DRUGS 10/CA SINGLE SHOT EPID (FL) W/DRUGS 10/CA PROCEDURAL (SHB)W/DRUGS + 10/CA CONTINUOUS EPIDURAL (EDD) OE GLS LOR + 10/CA CSE(FL)18G CSECURE,LOR GL 5ML,DRUGS 10/CA SINGLE SHOT EPIDURAL (EDD) W/DRUGS 10/CA CONTINUOUS EPIDURAL (EDD) W/DRUGS 10/CA SPINAL(SDD) 25G WHITACRE W/ DRUGS % 10/CA CONTINUOUS(FL)W/O DRUGS + 10/CA SINGLE SHOT (EDD) W/O DRUGS 10/CA CSE(FL)W/O DRUGS + 10/CA NERVE BLOCK (FL) W/O DRUGS 10/CA CONTINUOUS EPID (DD) W/DRUGS 10/CA SINGLE SHOT (EDD) W/DRUGS 10/CA NERVE BLOCK(SDD)W/O DRUGS + 30/CA SPINAL(FL)WHITACRE W/DRUGS AND DRUG LABELS % 10/CA SINGLE SHOT (SHB) W/O DRUGS 10/CA SINGLE SHOT EPID(SHB)W/DRUGS % 10/CA *PhO*-SPINAL (SHB) W/DRUGS 10/CA SPINAL(SDD) 27G QUINCKE W/DRUGS % 10/CA CONTINUOUS EPID (FL) W/DRUGS + 10/CA SINGLE SHOT (EDD)W/DRUGS + 10/CA SPINAL W/DRUGS (EDD) + 10/CA SPINAL (SDD) W/ DRUGS + 10/CA *PhO*-SINGLE SHOT (SDD) W/O DRUGS + 10/CA PEDIATRIC CONTINUOUS CAUDAL MINIPACK 18G CRAWFORD 10/CA SINGLE SHOT (SDD) W/DRUGS 10/CA SINGLE SHOT EPID(FL)W/O DRUGS+ 10/CA LOCAL ANESTHESIA (DD)W/O DRUGS + 10/CA *PhO*-SINGLE SHOT EPID(FL) W/O DRUGS + 10/CA *PhO*-SPINAL(SDD) W/O DRUGS (IOD) 10/CA SPINAL(DD)W/DRUGS % 10/CA CONTINUOUS EPID. MINIPACK TRAY16G*3IN TUOHY, 20G CATHETER 10/CA CONTINUOUS EPID(EDD)W/DRUGS + 10/CA CSE(FL)17G CSECURE,LOR GL 5ML,DRUGS + 10/CA SINGLE SHOT EPID(EDD)W/DRUGS + 10/CA SINGLE SHOT (LHB) W/DRUGS 10/CA SINGLE SHOT ( DD) W/ DRUGS 24/CA REG ANES MID-PACK 16G TUOHY % 10/CA CONTINUOUS EPID(EDD) 18G TUOHY W/DRUGS 10/CA S.A.S.SINGLE SHOT EPIDURAL(SHB)W/ODRUGS + 10/CA NERVE BLOCK(SHB)W/O DRUGS % 10/CA SPINAL(SDD) 24G W/DRUGS % 10/CA SPINAL (SDD) 22G WHITACRE W/DRUGS + 10/CA SPINAL ( SDD ) W/DRUGS 10/CA *PhO*-NERVE BLOCK (SDD) W/O DRUGS(IOD) + 10/CA SINGLE SHOT EPID(FL) W/O DRUGS + 10/CA CONTINUOUS EPID (EDD) W/DRUGS 10/CA SPINAL(EDD)W/DRUGS 10/CA SADDLE BLOCK (SDD)25G W/ DRUGS + 10/CA *PhO*-SPINAL (SDD) W/DRUGS AND DRUG LABELS + 10/CA Spinal (SDD) W/Drugs 10/CA PERIPHERAL NERVE BLOCK SINGLE SHOT (EDD) W/DRG 10/CA CONTINUOUS EPID (FL) W/O DRUGS(IOD) + 10/CA *PhO*-SPINAL TRAY(SDD)W/DRUGS + 10/CA SINGLE SHOT EPID(FL)W/DRUGS + 10/CA REGIONAL ANESTHESIA TRAY (DD) W/O DRUGS 10/CA SPINAL (SDD) W/ DRUGS AND DRUG LABEL 10/CA CONTINUOUS EPID(FL)W/O DRUGS % 10/CA NERVE BLOCK TRAY (LHB) W/O DRUGS & DRUG LABELS 10/CA CONTINUOUS EPID (DD) W/DRUGS 10/CA CSE(FL)W/DRUGS % 10/CA CONTINUOUS EPID (EDD) W/O DRUGS % 10/CA SPINAL TRAY ( SDD) W/DRUGS 10/CA CONTINUOUS EPID (EDD) W/DRUGS % 10/CA SINGLE SHOT EPID(EDD)W/DRUGS + 10/CA NERVE BLOCK (FL) W/O DRUGS 10/CA CERVICAL BLOCK (SHB) W/O DRUGS & DRUG LABELS + 10/CA SINGLE SHOT EPID (SDD) W/DRUGS + 10/CA CSE (EDD) W/DRUGS 10/CA + SPINAL PP (SHB) W/ DRUGS + 10/CA C0NTINUOUS EPID(FL)W/DRUGS % 10/CA CONTINUOUS EPID(FL)W/DRUGS 10/CA LUMBAR PUNCTURE (EDD) W/O DRUGS ELI LILLY + 10/CA EPIDURAL NEEDLE 17G HUSTEAD + 10/CA SINGLE SHOT EPID (DD) W/O DRUGS + 24/CA REGIONAL ANESTHESIA PREP TRAY 20/CA CONTINUOUS EPID(FL)W/O DRUGS + 10/CA SPINAL TRAY (SDD) W/DRUGS + 10/CA CONTINUOUS EPID(FL)W/DRUGS + 10/CA LUMBR(EDD)ADULT,22X31/2,VIAL,MAN,ANES TRAY + 10/CA SPINAL (SDD) W/DRUGS AND DRUG LABELS 10/CA SPINAL(FL)WHITACRE W/DRUGS % 10/CA NERVE BLOCK (EDD) W/DRUGS 10/CA Compressed Gauze Richmond Dental & Medical Gauze/sponge,nonresorbable for external use 7182/100 19604/50 KA2525/20 7825/24 7195/100 7172/50 4457/20 2636/25 7725/50 17474/20 7185/50 2648/24 908110 - Venture 2638/20 7870/20 4452/20 17480/20 9204/50 7120/50 2637/20 4425/24 7602/24 7737/50 7173/50 7040/50 7135/50 4455/20 7440/50 7188/50 7190/20 13636/24 7140/50 7125/50 7810/24 7502/24 11212/24 KA2550/25 4451/20 KA2540/20 7180/50 7150/50 4445/24 KA2520/20 7020/25 7176/50 17442/24 7172W/50 7706/50 908115 - Venture 7612/20 4415/24 7610/30 KA2580/50 KA2535/25 7210/25 7132/50 7733/50 7186/50 7720/50 2660/20 4435/24 11818/24 4456/20 7533/24 7504K/25 7510/24 7010/50 19401/20 KA25158/25 7130/50 908276 - Venture 7604K/24 7243/50 7880/20 7145/50 7806/24 7736/50 7746/50 7177/25 2680/20 2670/25 KA2530/25 KP1101/50 908272 - Venture TACgauze GAUZE ROLL BURN DRESSING TRICOTEX (PROFORE wound contact layer) Mercocel Venture Brand Gauze/Sponge Marker Pads and Marker Pens Surgical Marker, Ophthalmic Sepax kit CS-xxx.x and accessories AK-xxx, FA-xxx.x ; CryoSC cryobag FB-xxx.x CS-600.1 ART BMC Plus ART BMC CS-490.1 CS-900.X Centrifuge & accessorices for blood/bone marrow aspirate sequestration Ophthalmic Cannula, posterior capsular polishing, polyvinyl acetal Alcon Microsurgical Instruments K862167 MINI TRACH II + 10/BX Portex Mini Tach II Speedboat RS2 Folders & Injectors, Intraocular Lens (IOL) Raysert' Single Use Soft Tipped Small Incision Disposable Injector, Model R- Tonosafe PICO 7Y Single Use Negative Pressure Wound Therapy System PICO Single Use Negative Pressure Wound Therapy System (includes sterile pump) PICO Single Use Negative Pressure Wound Therapy System BANDAGE ELASTIC COTON BULK NON STERILE 2 inch 3 inch 4 inch 6 inch SPONGES GAUZE NON STERILE BULK 4X4 16PLY SPONGES GAUZE NON STERILE BULK 3X3 12 PLY SPONGES GAUZE NON STERILE BULK 4X4 16PLY GAUZE WASHED BOLT NON STERILE BULK TOWELS COTTON NON STERILE BULK SPONGES GAUZE NON STERILE BULK 2X2 8 PLY COTTON BALLS MEDIUM AND LARGE NON STERILE BULK STOCKINETTE COTTON APPLICATOR ABSORBENT TIPPED NON STERILE BULK SPONGES GAUZE NON STERILE BULK 4X4 8 PLY SPONGES GAUZE NON STERILE BULK 4X4 12 PLY Surgical Instrument Kit Disposable Sterilized Convenience Kit ACL DISPOSABLE KIT PDP101/20 CIR011/20 BBF005/10 TRT120/10 CHT007/20 CHT009/20 9204/20 UCPT01/10 SUTGEN001/100 VST405/20 LAC137/20 DISPOSABLE PERCUTANEOUS PACK FOR C617X REUSABLE GUIDES BBF001/10 CHT013/20 DBFK01/10 LAC141/20 BBF007/10 BBF002/10 HDT300/20 SMR001/20 LAC147/20 LAC134/20 THT706/20 HDT010/10 DCNS01/20 ENDO01/20 LAC107/20 CHT032/20 VST406/20 PBT001/20 EMR009/20 ENT003/20 NSL008/20 LAC109/20 LAC701/20 LAC122/20 SJT001/10 SNBS01/05 CDT703/05 CIR-1937 DBR001/20 CHT010/10 CIR001/20 ENT002/10 CHT005/20 CHT007/10 PWL001/20 TBT100/10 SMH001/05 24-685/20 SUT112/50 OKD001/10 EMR707/10 CHT004/10 LAC133/20 UBT001/20 BBF012/05 CJD006/01 PLT001/20 DERM01/20 NSL001/20 BMB001/20 TRT125/10 LAC146/20 BBF009/10 NHH001 PART 1 17472/20 SUT036/20 SSK119R/06 BBF015/05 ToggleLoc 2.9 0TOQ234 SUT009/20 PRP101/25 EMR007/20 SUT120/20 SSK124/06 TRT110/20 EPI002/20 SUT113/50 LAC103/20 DRS001/50 CIR220A/20 EMR013/20 INC03/20 SUT125/50 ASB001/10 PCRS01/10 Y-KNOT FLEX DISPOSABLE PERCUTANEOUS PACK FOR Y-G00X REUSABLE GUIDES HIP ARTHROSCOPY DISPOSABLE KIT ANATOMIC ACL DISPOSABLE KIT CPCT01/20 BBF008/10 SSK120/06 CHT012/20 SPIP01/20 BPT408/20 SUT106/50 JuggerLoc Y-KNOT FLEX 1.3MM DISPOSABLE PERCUTANEOUS PACK WITH T-GUIDE MOK001/50 SUT292/50 INST10/50 IUDKS1/20 LAC131/20 SUT130/50 HPK002/20 DCPD01/20 STARNT/20 CBK018/20 SUT035/20 DBR006/50 CJD001/01 19082/20 PLV014/20 NCK400/10 SUT866/50 HDT200/20 CJD003/01 PRK001/20 ENT003/10 TRT710/05 OBG001/20 PRP009/20 MPP001/20 SSK125/06 TRT122/10 NSL003/20 LAC117/20 ASB002/10 TRT121/10 UNIVERSAL ACL DISPOSABLE KIT CIR100/20 MHH001/10 CJD002/01 DCK001/10 CHT010/20 BBF006/10 INST11/20 EMR710/10 CGCM01/10 BBT003/20 INC15/20 TOQ232 DPHP01/20 CHT019/20 LAC139/20 LAC138/20 CDT701/05 CIR601/20 NBT001/5 CIR039/20 BBF011/10 NAZB01/10 SUT123/20 CJD005/01 TRT126/10 SSK119/06 DRS006/20 SBT210/20 LAC132/20 LAC290/20 CHT002/20 EMR002/20 BBF013/10 OEPT01/20 DERM02/20 PRP008/20 SUT401/50 LAC333/20 LAC126/20 LAC866/20 MST202/20 SSK149/06 DCH002/20 WHK002/50 LAC142/10 MOK001/25 LAC121/20 SSK121/06 NPT002/20 QMC001/10 EMR008B/20 BPT406/20 NCK310/10 TOQ233 VAT706/20 PBF001/10 DBR009/20 PCT001/20 CDT202/20 VT 100 Y - Connector THT001/10 MOHS02/20 PCK001/20 BFK001/10 LAC501A/50 MGH001/10 CHT015/10 SPA001/20 THT201/20 CHT021/10 SSK100/06 TRT019/10 NHH001/05 OBG004/20 BBF018/10 TOQ234 VT Drape and Port Set Kit S Lock CHT006/10 PLV013/20 SUT110/20 PLT002/10 KHBF01/10 LAC124/20 DAT001/10 Carilex VT Extension Tube CIR010/20 FPK013/20 INC40/20 SUT121/20 LAC120/20 CPDK01/100 BBF014/10 CHT030/10 LAH001/10 SUT124/50 ADK001/05 CIR301/20 VT Port Set Kit VT Drape 5pcs pack VT Circle Drape 5pcs pack VT Drape and Port Set Kit L Lock VT Drape and Port Set Kit M Lock Surgical Instrument Tray (SIT) Kit GENERAL PURPOSE KIT, INCISION AND DRAINAGE KIT VT. 100 Y - Connector JuggerLoc and ToggleLoc 2.9 MedOne WishBone Convenience Kit Exufiber Ag+ SmartSet HV Bone Cement 20g SmartSet HV Bone Cement 40g SmartSet HV Bone Cement MAPC Probe 2.3 x 2200 Radial Argon MAPC Probe 1.5 x 3000 Axial Argon MAPC Probe 3.2 x 2200 Axial Argon MAPC Probe 2.3 x 2200 Lateral Argon MAPC Probe 2.3 x 2200 Axial Argon MAPC Probe 2.3 x 3000 Axial Argon MAPC Probe 1.5 x 1500 Axial Argon GUIBOR CIS SET C-LINE CIS SET FIBEROPTIC CIS SET Valve Adapter Argyle Penrose Tubing SuperClip Accessories, Catheter Peritoneal Lavage drainage needle/catheter "Prelude SNAP 165 Valved Splittable Sheath Introducer ULTRAPERC LOCAL INFILTRATION (SDD) W/DRUGS + 10/CA Portex UltraPerc Local Infiltration Tray Portex Ultraperc ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 7MM BLU TUBE +2/CA Portex UltraPerc Singl ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 8MM BLUS TUBE +2/CA Portex UltraPerc Sin ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 9MM BLU TUBE +2/CA Portex UltraPerc Sing K041348 ULTRAPERC PERC S/S DILATION TRACHY KIT FOR 7, 8, 9MM TUBES, SOFT INTRODUCERS, 2/CA Portex UltraPerc Percutaneous T ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 7MM BLUS TUBE +2/CA Portex UltraPerc Sin ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 8MM BLU TUBE +2/CA Portex UltraPerc Sing ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 9MM BLUS TUBE +2/CA Portex UltraPerc Sin Xience V OTW Xience V RX Xience XPEDITION OTW Drug Eluting Stent System Xience XPEDITION RX Drug Eluting Stent System Xience Xpedition OTW LL Xience Alpine OTW Xience Xpedition RX SV Xience Xpedition OTW SV Xience Prime Xience Alpine RX XIENCE Sierra RX Xience Prime LL Xience Xpedition OTW Xience Xpedition RX LL Xience Xpedition RX 0.2 µm filter for priming cardiopulmonary bypass circuits with 3/8 ALLEVYN Ag Dressings (includes Ag Gentle Border) AQUACEL Foam Super absorbent woven Eclypse Adherent Sacral Foam/silicone Advazorb Silflo/Silflo Lite Foam/silicone Advazorb/Advazorb Lite (Advazorb Plus) Super absorbent woven dressing Eclypse Boot Woven Eclypse Woven Ecylpse Adherent Mepore Pro / Ultra Foam/silicone Advazorb Silfix/Silfix Lite Non woven ribbon dressing Advadraw Spiral Non woven dressing Advadraw Dressing, Wound Hydrophilie Triad Foam Wound Dressings - 004766,004781,004782,003900, 003901,003902,003903,003904, 001502,001042, 005085 Zetuvit (plus) Advazorb Fixation Advadraw Zorflex ZF20 Zorflex ZF10 Eclypse Contour Zetuvit Plus Silicone (Border) Advazorb Heel Eclypse Adherent Advazorb Sacral Zorflex ZF15 Advazorb Areola Advadraw Spiral Advazorb Eclypse Foot Advazorb Silfix Eclypse Boot Eclypse Border & Border Oval Advazorb Border Lite Eclypse Advazorb Border Eclypse Adherent Sacral ConvaFoam Border ConvaFoam Non-Adhesive AQUACEL Foam Pro ConvaFoam Silicone Exufiber Protector, skin pressure 91101 SuperBump NSP001/10 8514/50 2629 KNEEPAD/25 8541/50 M-408-10 17133/20 1749/20 907-GP-10 FBP12/25 PPPS05/10 SteriBump 803-GP-10 8512/50 8522/50 7905W/20 8513/50 17434/24 8520/50 1742/25 17023/50 17408/20 7907W/03 KNEEPLACER/10 8527/50 1743/25 8555/20 17145/20 15516/24 17519/24 8525/50 16120/24 8544/100 8511/50 8533/100 1742/10 8542/100 7901W/25 7908W/03 17412/20 17410/50 7904W/10 PPPS01/10 8514/25 8515/25 8516/50 7908W/25 17424/50 1744/25 1747/20 1745/25 17792/50 17411/20 17590/20 17413/20 PPPS08/10 MEG012/20 17430/25 14120/24 17524/50 1746/20 8543/10 1741/50 8523/50 7909W/03 8541/40 8511/20 907-GPE-10 7903W/25 508-E 803-GPE-10 Allevyn Life CAST PADDING ALLEVYN Complete Care 824-P Lid Implant AVELLE Negative Pressure Wound Therapy Dressing Avelle 3315020 DePuy CMW 1 Gentamicin Bone Cement DePuy CMW 1 Gentamicin Bone Cement 545031500 DePuy CMW 1 Gentamicin Bone Cement 20g SmartSet GHV Gentamicin Bone Cement 545035500 SmartSet GHV Gentamicin Bone Cement 40g SmartSet GHV Gentamicin Bone Cement 3095020 SmartSet GHV Gentamicin Bone Cement PICO Single Use Negative Pressure Wound Therapy System D.O.R.C. VFI/VFE system VT Dressing Kits PICO 14 Single Use Negative Pressure Wound Therapy System PK Button Parallax T-Grip Access Needle Autologous Platelet Concentrator Fluid Transfer Device (FTD) Access Tool, Filler Placement Stylet nContact Cannula Caps-Lock Ultra Access Tool, Filler Placement Set VertecoR MidLine Osteotome 3 Ad-Tech Cannulas Cannula Surgical General and Plastic Surgery Cassi 2 Needle MEDTRONIC Facet Screw Instruments Bone Plug And Obturator ACL Disposable Kit Facet Screw Insruments 2-CAN Integra; Jarit; MicroFrance; Miltex; Padgett; Xomed Topaz EPF Cannula System Repris Bladder Injector (1017) Cranioplastic Confidence High Viscosity Spinal Cement PICO 7 Single Use Negative Pressure Wound Therapy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2024-10-21
NZP	Sealant, Microbial	General, Plastic Surgery	Class 2	878.4370	2013-01-13
KRJ	Filter, Prebypass, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4280	2013-02-04
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2019-12-19
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2012-12-14
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2025-06-26
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2019-12-19
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2013-01-13
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-11-16
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2026-03-19
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2026-03-19
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2025-07-02
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2013-02-04
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2025-06-26
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-11-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-07-18
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-11-01
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-02-01
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2013-01-13
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2012-11-08
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2013-01-31
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2013-01-31
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2013-01-31
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-01-31
FCS	Light, Catheter, Fiberoptic, Glass, Ureteral	Gastroenterology, Urology	Class 2	876.4020	2020-11-24
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2021-03-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-09-22
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-12-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-19
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2026-03-19
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2026-03-19
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2013-01-13
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2012-11-20
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2012-10-29
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2026-03-19
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2012-11-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-01
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2012-11-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-08-15
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2013-02-04
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2012-11-20
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2019-08-15
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2013-02-04
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2013-02-04
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-05-29
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2013-01-13
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-05-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-07-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-07-02
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2019-07-02
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-05-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-03-19
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-01-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-08-15
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2012-11-16
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-11-28
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2019-12-19
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2012-11-20
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2013-01-13
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2013-01-13
KRJ	Filter, Prebypass, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4280	2013-02-04
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2021-04-22
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-12-11
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-02-04
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2012-11-12
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2013-02-04
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2019-12-19
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-05-29
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2013-02-01
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-02-01
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-01-31
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2013-01-31
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2013-01-13
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2012-11-29
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-02-18
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2021-06-09
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2013-02-04
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2019-07-02
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2021-03-05
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-01
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2013-02-01
MIA	Needle, Spinal, Short Term	Anesthesiology	Class 2	868.5150	2021-04-22
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2025-06-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-06-27
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-05-29

Official Correspondent

Karen Whaley-Krumins

US Agent Details

Chris Eustace Email: ceustace@sterigenics.com Phone: (630) 9281700

Related Public Records

Same Entity

Sotera Health LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005914490	UNIDADE DE ESTERILIZACAO COTIA LTDA.	Cotia Sao Paulo, BR
9680579	Sterigenics Radiation Technologies Canada, Inc	PORT COQUITLAM British Columbia, CA
3008132411	Sterigenics Shanghai E Beam Ltd.	Shanghai, CN
9616517	Sterigenics S. de R.L. de C.V.	Tepeji del Rio de Ocampos Hidalgo, MX
3008328679	Sterigenics S. de R.L. de C.V.	Cuautitlan Izcalli Mexico, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K172288	Wilson-Cook Medical Inc./Cook Endoscopy	Fusion OMNI Sphincterotome	2018-04-17
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0210-2022	Covidien Llc	2	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

Similar Registrations

Registration Number	Establishment Name	Location
9681260	Boston Scientific Limited	GALWAY, IE
2024168	ABBOTT VASCULAR	Temecula, CA, US
2124215	Boston Scientific Corporation	Saint Paul, MN, US
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
1000121056	Boston Scientific Corporation	Coventry, RI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008132398. Last updated year: 2026. Please use registration number 3008132398 when referencing this establishment in official correspondence.