Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611665

FEI Number

3002807095

Entity Name

Sterigenics EO Canada, Inc.

City/State/Country

Mississauga Ontario, CA

Establishment Address

400 Ambassador Drive, Mississauga Ontario L5T 2J3, CA

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

BD Luer Accessories Kangaroo Milk Straw: 462000E Kangaroo Milk Straw: 461000E Kangaroo Milk Straw: 464000E LUNA-100 Dual Floating Dialysis catheter OWL STERILE SINGLE USE CANNULAE FALLER STYLET Crescent Right Atrial Visitec Crawford Intubation Lumohs Loader Lumohs Scalpel Blade, Scalpel BEAVER NEEDLE BLADE 1.5MM CUTTING EDGE BEAVER CATARACT BLADE 19MM L X 1.4MM W BEAVER SCLEROTOME KNIFE SHARP ALL AROUND BEAVER TYMPANOPLASTY BLADE 2.5MM W 60 BEVEL DOWN BEAVER ARTHRO-LOK ROUNDED TIP 4MM BLADE BEAVER BENT BLADES 45 SHARP ALL AROUND BEAVER OPTIMUM BLADE 22.5 STRAIGHT BEAVER NEEDLE BLADE 5MM CUTTING EDGE BEAVER TYMPANOPLASTY BLADE 2MM W 50 BEVEL DOWN BEAVER SICKLE EDGE BLADE 5MM BEAVER ARTHRO-LOK POINTED RETROGRADE 4MM BLADE BEAVER NEEDLE BLADE 3MM CUTTING EDGE BEAVER ARTHRO-LOK MINI-MENISCUS 4MM BLADE (FLAT) BEAVER SLIT BLADE 1.5MM STRAIGHT BEAVER POCKET SCLERAL KNIFE 3MM 60 BEAVER CATARACT BLADE 20.5MM L X 1.7MM W BEAVER POCKET BLADE 3MM W 60 BEVEL DOWN BEAVER OPTIMUM BLADE 45 STRAIGHT BEAVER OPTIMUM BLADE 15 STRAIGHT BEAVER MINI-BANANA BLADE (FLAT) 4MM BEAVER SCLEROTOME BLADE MULTI-SIDED BEAVER BLADE BEAVER BEAVERGUARD GUARDED .50MM DEPTH BLADE BEAVER MINI-BLADE SURGICAL BLADE 180 BEAVER ARTHRO-LOK HOE 60 4MM BLADE BEAVER ARTHRO-LOK ROUNDED TIP 4MM BLADE (FLAT) BEAVER ARTHRO-LOK MINI-BANANA 4MM BLADE BEAVER NEEDLE BLADE 7MM CUTTING EDGE BEAVER CATARACT BLADE 25.5MM L X 2.2MM W BEAVER SLIT BLADE 3MM 45 BEVEL UP BEAVER BEAVERGUARD GUARDED .35MM DEPTH BLADE BEAVER SLIT BLADE 3MM STRAIGHT BEAVER POCKET CRESCENT BLADE 2.5MM 55 BEVERL UP BEAVER OPTIMUM BLADE 30 STRAIGHT BEAVER SLIT BLADE 3MM 45 BEVEL DOWN BEAVER SLIT BLADE 3.2MM 45 BEVEL DOWN BEAVER ARTHRO-LOK POINTED TIP CURVE L 4MM BLADE BEAVER POCKET BLADE 2.25MM W 60 BEVEL UP BEAVER CERVICAL BIOPSY BLADE BEAVER MICRO-BLADE 15 BEAVER TYMPANOPLASTY BLADE 2.5MM W STRAIGHT BEAVER SLIT BLADE 2.8MM 45 BEVEL DOWN BEAVER MICRO-BLADE 30 BEAVER ARTHRO-LOK MINI-MENISCUS 4MM BLADE DermaPlane BEAVER POCKET SCLERAL KNIFE 2.25MM 60 BEAVER ARTHRO-LOK BANANA 4MM BLADE BEAVER ARTHRO-LOK RETROGRADE 4MM BLADE BEAVER ARTHRO-LOK ROSETTE 4MM BLADE DermaBlade Surgical 15 blades Dermaplane 10S bladkes Surgical 11 blades Surgical 10 blades Single Use #11 Safety Scalpel Single Use #15 Safety Scalpel Safety Cartridge #11 Carbon Steel Blade Orange Cartridge Safety Cartridge #10 Stainless Steel Blade Green Cartridge Safety Cartridge #15 Carbon Steel Blade Red Cartridge Argon Medical Scalpels Safety Cartridge #10 Carbon Steel Blade Purple Cartridge Safety Cartridge #11 Stainless Steel Blade Blue Cartridge Safety Cartridge #15 Stainless Steel Blade Yellow Cartridge Single Use #10 Safety Scalpel Short/Long Handle Scalpels Safety scalpel Scalpel Blades Phlebotomy Bag Sets OWL STERILE SINGLE USE CANNULAE PERITONEAL DIALYSIS CATHETERS AND ADAPTERS Starswab Anaerobic Transport System Labtician Lid Load CANNULA SEAL,ENDOWRIST STAPLER,IS3000 (PN 410351-03) VitalFlow Set 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 Arctic Front cardiac cryoablation catheter Freezor MAX Cardiac Cryoablation Catheter Freezor MAX cardiac cryoablation catheter Arctic Front Advance cardiac cryoablation catheter ASSY,FENESTRATED BIPOLAR FORCEPS,SINGLE SITE,6-PAK (PN 428093-13) Xi Single Site Fenestrated Bipolar Forceps - 478093 SINGLE-SITE PORT,8.5MM ENDO,BOX OF 10 (PN 428065-03) Pristine Arthroscopic Visualization System Summit Arthroscope 329.634S 329.632S 3601S 351.27S 329.633S 35986S 35113S PLASTIC TEMPLATE FOR CATHETER PLACEMENT GRAFT PASSING GUIDE PIN, STERILE, 2.4 X 432MM (93 X 17IN) HIGH STRENGTH GUIDE PIN, 14 IN, STERILE, 2.4 X 356MM (93 X 14IN) HIGH STRENGTH GUIDE PIN, 12 IN, STERILE, 2.4 X 305MM (93 X 12IN) LCS PAT PLAN REP BASK STD/STD+ GLOBAL AP BALL CYLIN TRL ASSEM GLOBAL AP REVISION TRL INSERT MISHA Knee System Targeting Kit MISHA Knee System Trial FlexCath steerable sheath Noncor Infusion Sets CRAWFORD LACRIMAL INTUBATION SET (W; T SUTURE); WITHOUT SUTURE) Crescent Bicaval Heart Lung Tubing packs Heart Cooling Jacket Central Venous Access Tray Si Cannula Seal - 400077 Si Cautery Spatula, A-Sure (5mm) - 400160 STYLET Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems Percutaneous Peritoneal Dialysis Catheter Implantation Systems Laparoscopic Peritoneal Dialysis Catheter Implantation System Irrigating Syringe IRRIGATION TRAY Thumb control piston irrigation syringe 60cc ST Flat top piston irrigation syringe 60cc ST Piston enteral irrigation syringe 60cc NS Enteral irrigation syringe 60cc NS EAR BULB SYRINGE Bulb irrigation syringe 60cc ST RXP (Rapid Exchange Flushing Syringe Igloo Wound Irrigation System Igloo Wound Irrigatior Standard Trach Care Kit Soft tray W/ Piston Syringe ABSCESS CAP Soft-Flow Aortic OWL STERILE SINGLE USE CANNULAE Opus Valve Adapter Argyle Penrose Tubing SuperClip Accessories, Catheter Peritoneal Lavage drainage needle/catheter "Prelude SNAP 165 Valved Splittable Sheath Introducer Line Clamps Enema Catheter Nautilus Base and Smart Foresight ICE Catheter Cautery Tip TIP; WALSH MEDICAL DEVICES INC. CAUTERY Suction conneting tube Aspiration Tubing OWL STERILE SINGLE USE PROBES Wright Ptosis Support Sling EndoRelease Cubital Tunnel Release System Hex-Flex with disposable obturalor DryDoc Cannula Reprocessed Arthroscopic Accessories Hi-Flow Cannula FlowPort Cannula SharpShooter Handle Universal Cannula SafeGuard Carpal Tunnel Release System INTEQ Suturing kit Hex-Flex Disposable Cannula Hip Preservation Sys Cannula, Cannuloc, disposable Scope Shield Blitz Suture Retriever Astroscopy Cannula CapsulePass Suture Passer Ceterix Disposable Knot Pusher TwoVu ST-6-134 FirstPass ST Suture Passer, Self Capture TwoVu ST-5 ClearVu 2.7 Blunt Exstravastopper FirstPass ST Suture Passer, Standard TwoVu ST-6L Y-KNOT FLEX HIP DISPOSABLE FLEXIBLE OBTURATOR, BLUNT TwoVu ST-6 Y-Knot HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 8 X 85MM, QTY 6 Integra Endorelease Cubital Tunnel Release System 8 X 120MM HIP PRESERVATION SYSTEM ARTHROSCOPY CANNULA, QTY 6 5.5MM (I.D.) X 70MM SHOULDER CANNULA SET WITHOUT FENESTRATIONS, 10 EA 8.4MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA ClearVu 2.7 Sharp DryVu BLITZ SUTURE RETRIEVER, STRAIGHT, 6 EA 5.5MM (I.D.) X 70MM UNIVERSAL CANNULA SET WITH FENESTRATIONS, 10 EA 6.5 X 73MM CLEAR FLEXIBLE CANNULA, 6 EA Adjustable Retractor Cannula 6mm x 65mm DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 8 X 85MM, QTY 6 Y-Knot, Flex Disposable Flexible, Trocar Adjustable Retractor Cannula 6mm x 85mm with outflow DRY DOC CANNULA WITH DISPOSABLE OBTURATOR 8 X 75MM, QTY 6 HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 7 X 85MM, QTY 6 6MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA TwoVu ST-6-130 CANN DRY DOC 8.4X75MM 6 EA 8.4MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 5 X 85MM, QTY 6 DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR, 5 X 85MM, QTY 6 8.4MM X 50MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA Adjustable Retractor Cannula 8mm x 65mm 8.4MM X 50MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA CrossFix II Disposable Kit DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR, 6 X 85MM, QTY 6 6MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA 8.4MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA HIP PRESERVATION SYSTEM HIP ACCESS NEEDLE PACK, 17G, QTY 2 6MM X 50MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA HEX-FLEX CANNULA WITH DISPOSABLE OBTURATOR 6 X 85MM, QTY 6 6.5MM X 73MM CLEAR FLEXIBLE CANNULA THREADED, QTY 6 6MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, SMOOTH, 6 EA Y-Knot, Flex Disposable Flexible Obturator, Blunt DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 7 X 95MM, QTY 6 8.4MM X 75MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA DRY-DOC CANNULA WITH DISPOSABLE OBTURATOR 7 X 85MM, QTY 6 6MM X 90MM DISPOSABLE CANNULA W/OBTURATOR, THREADED, 6 EA HIP PRESERVATION SYSTEM SWITCHING STICK PACK, QTY 1 Adjustable Retractor Cannula 8mm x 85mm 0234-020-165;3910-075-500;3910-075-501;3910-075-650;3910-075-651;3910-075-800;3910-090-650;3910-090-800 Arthroscopic Accessories Cubital Tunnel Release System EGR System Accessories, Arthroscopic MicroAire Endoscopic Release System - Various Accessories 3910-090-500 3910-075-801 Remote Control Drape Sharpshooter Endoscopic Gastroc Release (EGR) System Dry Doc Cannula W/Disp. Obturator Disposable Cannula Flexible Cannula CMI Measuring Rod (dose audit) CMI Measuring Rod (Production) Dry Dooc Cannula, Non Fenestrated Cannuloc, disposable cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2013-04-17
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-07-30
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2023-11-09
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2023-11-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-11-09
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-07-25
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2025-08-01
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2014-07-08
PZS	Dual Lumen Ecmo Cannula	Cardiovascular	Class 2	870.4100	2024-12-12
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2013-05-02
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-11-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-07-25
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-07-25
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2013-07-25
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2013-07-25
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2014-07-08
JSL	Culture Media, Anaerobic Transport	Microbiology	Class 1	866.2390	2013-07-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-07-25
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2013-07-25
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-07-05
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2023-11-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-11-09
BYS	Oxygenator, Long Term Support Greater Than 6 Hours	Cardiovascular	Class 2	870.4100	2024-12-12
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	Cardiovascular	Class 2	870.4100	2024-12-12
QWF	Tubing, Long Term Support Greater Than 6 Hours	Cardiovascular	Class 2	870.4100	2024-12-12
QJZ	Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure	Cardiovascular	Class 2	870.4100	2024-12-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-11-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-07-25
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2013-04-23
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-07-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-07-05
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-07-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-07-05
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2019-07-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-11-09
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2025-07-09
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2025-07-30
HWT	Template	Orthopedic	Class 1	888.4800	2013-07-17
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2013-04-23
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2013-07-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-07-25
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2012-12-14
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2025-07-30
HQJ	Implant, Absorbable, (Scleral Buckling Methods)	Ophthalmic	Class 2	886.3300	2012-12-10
PZS	Dual Lumen Ecmo Cannula	Cardiovascular	Class 2	870.4100	2024-12-12
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-07-25
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-06-20
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2014-07-08
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2012-11-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-07-25
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-12-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-11-09
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2023-11-09
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2025-08-01
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-12-12
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-11-28
FKK	Clamp, Line	Gastroenterology, Urology	Class 1	876.4730	2013-07-25
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2013-07-25
BYS	Oxygenator, Long Term Support Greater Than 6 Hours	Cardiovascular	Class 2	870.4100	2024-12-12
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2023-08-17
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-08-17
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-08-17
ORD	Optical Coherence Tomography, Intravascular Catheter	Cardiovascular	Class 2	870.1200	2023-08-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-07-25
HQR	Apparatus, Cautery, Radiofrequency, Ac-Powered	Ophthalmic	Class 2	886.4100	2013-07-25
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2012-11-01
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2013-07-25
HJZ	Crutch, Ptosis	Ophthalmic	Class 1	886.5600	2013-07-25
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2012-10-31

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.

View Entity Profile →

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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

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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611665. Last updated year: 2026. Please use registration number 9611665 when referencing this establishment in official correspondence.