Sterigenics U.S., LLC

FDA Device Registration & Listing · Tustin, CA, US · Registration 2022435

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2022435
FEI Number
2022435
Entity Name
Sterigenics U.S., LLC
City/State/Country
Tustin, CA, US
Establishment Address
1401 Morgan Cir, Tustin, CA 92780, US
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Endovascular Embolization Coil; Syringe Kit MicroPlex; HydroCoil; HydroLink (MS) HORIZON PROCESS WATER/10CC STERILE WATER FILLED SYRINGE (MS) CG3076 - 10 CC STERILE WATER FILLED LATX FREE SYR, (MS) 5CC STERILE WATER FILLED LATX (MS) 5 CC STERILE WATER FILLED LATX FREE SYR, (MS) CG50080 -HORIZON PROCESSED WATER 30 CC LTX STER WTR SYR (MS) 10 CC STERILE WATER FILLED LATX (MS) 20 CC STERILE WATER FILLED SYRINGE, TELEFLEX (MS) PK 119 - 10CC STERILE WATER FILLED LATEX FREE SYRINGE, (MS) 10 CC STERILE WATER FILLED LATEX FREE (MS) 310CC STERILE WATER FILLED LAT 10CC STERILE WATER FILLED LATX (MS) 30 CC STERILE WATER FILLED LATEX FREE SYRINGE 30 cc STERILE WATER FILLED LATEX FREE SYRINGE 10CC SYR, 5CC STERILE WATER FI (MS) CG3151 - 3.5 CC STERILE WATER FILLED SY Argon Angiography Drape OR Towel, Drapes Column Drape KP11827/250 IS4200 Arm 4 Proximal Drape - 470473 Xi Column Drape - 470341 IF1000 Vision Probe Bag - 490127 (MS) CG0985 - HORIZON STERILUB LUBRICATION (MS) BARD-STERILUB LUBRICATION GEL TUBE, 8G, SNAP VAC GRANUFOAM SILVER MEDIUM DRESSING WITH SENSATRAC - 5 PACK VAC GRANUFOAM SILVER SMALL DRESSING WITH SENSATRAC - 10 PACK VAC GRANUFOAM SILVER SMALL DRESSING WITH SENSATRAC - 5 PACK VAC GRANUFOAM SILVER LARGE DRESSING - 5 PACK VAC GRANUFOAM SILVER MEDIUM DRESSING WITH SENSATRAC - 10 PK VAC GRANUFOAM SILVER SMALL DRESSING - 5 PACK VAC GRANUFOAM SILVER LARGE DRESSING WITH SENSATRAC - 5 PACK VAC GRANUFOAM SILVER MEDIUM DRESSING - 5 PACK SENSATRAC, LARGE SILVER GRANUFOAM DRESSING 10 PACK InfoVAC with Gel, 10 Pack InfoVAC without Gel, 10 Pack INFOVAC CAN ASSY, W/O GEL, 5 PK INFOVAC CAN ASSY, W/ GEL, 10 PK INFOVAC CAN ASSY, W/O GEL, 10 PK V.A.C. WhiteFoam Dressings Vial adaptor spike CODAN Vial adaptor Spike 30 Multi-Unit Abut. 4.5 mmH compatible with: Astra Tech Implant System 3.5/4 Multi-Unit Abut. 4.5 mmH compatible with: Astra Tech Implant System 4.5/5 Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 4.5/5 Multi-Unit Abut. 1.5 mmH compatible with: Astra Tech Implant System 3.5/4 30 Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 4.5/5 17 Multi-Unit Abut. 2.5 mmH compatible with: Astra Tech Implant System 3.5/4 17 Multi-Unit Abut. 2.5 mmH compatible with: Astra Tech Implant System 4.5/5 30 Multi-Unit Abut. 4.5 mmH compatible with: Astra Tech Implant System 4.5/5 Multi-Unit Abut. 2.5 mmH compatible with: Astra Tech Implant System 4.5/5 Multi-Unit Abut. 2.5 mmH compatible with: Astra Tech Implant System 3.5/4 17 Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 3.5/4 Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 3.5/4 30 Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 3.5/4 17 Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 4.5/5 Multi-Unit Abut. 1.5 mmH compatible with: Astra Tech Implant System 4.5/5 GM Ultra, 7G, EnCor GM Ultra, Titanium, ¿S¿ GM Ultra, 10G, EnCor GM Ultra, EnCor 360 GM Ultra UltraCor, 17G, SS ULTRACOR MRI INTRODUCER SET ClotTriever Catheter SP Camera Instrument Sheath - 430020 SP1098 Entry Guide - 430022 SP Drape - 430013 SP Instrument Sheath - 430012 SP Monopolar Scissors Tip - 430035 800936-003 CPT2000 Trigger No Hole AMT Manifold 800936-002 CPT2000 NHB Manifold 800936-004 CPT2000 Alternative Material, Manifold Kit CPT2000 Automated Manifold Kit ACTIVAC STERILE FLUID PATH (SFP) CANISTER ASSY, W/ GEL 5 PK VAC GRANUFOAM SILVER MEDIUM DRESSING WITH SENSATRAC - 5 PACK VAC EXTRA LARGE DRAPE, STAND ALONE, 5 PACK. ACTIVAC STERILE FLUID PATH (SFP) CANISTER ASSY, W/ GEL, 10 Multi-Unit Abut. 1.5 mmH compatible with: NobelActive RP Multi-Unit Abut. 2.5 mmH compatible with: NobelActive NP Multi-Unit Abut. 1.5 mmH compatible with: NobelActive NP 30 Multi-Unit Abut. 4.5 mmH compatible with: NobelActive RP 30 Multi-Unit Abut. 4 mmH compatible with: Branemark System RP Multi-Unit Abut. 1.5 mmH compatible with: Straumann Bone Level NC 17 Multi-Unit Abut. 3.5 mmH compatible with: NobelActive RP 17 Multi-Unit Abut. 3 mmH compatible with: Branemark System RP 17 Multi-Unit Abut. 3.5 mmH compatible with: Straumann Bone Level NC 30 Multi-Unit Abut. 3.5 mmH compatible with: NobelActive NP Multi-Unit Abut. 3.5 mmH compatible with: Straumann Bone Level RC 30 Multi-Unit Abut. 4.5 mmH compatible with: Straumann Bone Level RC Multi-Unit Abut. 2 mmH compatible with: Branemark System RP 30 Multi-Unit Abut. 5 mmH compatible with: Branemark System RP 17 Multi-Unit Abut. 2 mmH compatible with: Branemark System RP 30 Multi-Unit Abut. 3.5 mmH compatible with: NobelActive RP Multi-Unit Abut. 1.5 mmH compatible with: Straumann Bone Level RC 17 Multi-Unit Abut. 2.5 mmH compatible with: Straumann Bone Level NC Multi-Unit Abut. 4.5 mmH compatible with: Straumann Bone Level RC 17 Multi-Unit Abut. 3.5 mmH compatible with: NobelActive NP Multi-Unit Abut. 4.5 mmH compatible with: NobelActive RP 17 Multi-Unit Abut. 3.5 mmH compatible with: Straumann Bone Level RC 30 Multi-Unit Abut. 4.5 mmH compatible with: NobelActive NP 17 Multi-Unit Abut. 4 mmH compatible with: Branemark System RP Multi-Unit Abut. 2.5 mmH compatible with: Straumann Bone Level RC Multi-Unit Abut. 5 mmH compatible with: Branemark System RP Multi-Unit Abut. 2.5 mmH compatible with: NobelActive RP Multi-Unit Abut. 1 mmH compatible with: Branemark System RP Multi-Unit Abut. 3.5 mmH compatible with: Straumann Bone Level NC 17 Multi-Unit Abut. 2.5 mmH compatible with: NobelActive NP Multi-Unit Abut. 3.5 mmH compatible with: NobelActive RP 17 Multi-Unit Abut. 2.5 mmH compatible with: Straumann Bone Level RC Multi-Unit Abut. 3 mmH compatible with: Branemark System RP 30 Multi-Unit Abut. 3.5 mmH compatible with: Straumann Bone Level RC Multi-Unit Abut. 3.5 mmH compatible with: NobelActive NP Multi-Unit Abut. 2.5 mmH compatible with: Straumann Bone Level NC 17 Multi-Unit Abut. 2.5 mmH compatible with: NobelActive RP Intraocular stents and associated insertion devices Model G3 iStent Intraocular stents and associated insertion devices Model G2-M-IS Intraocular stents and associated insertion devices Model GTS100L/R Intraocular stents and associated insertion devices Model GTS100i Multi-Unit Abut. 5 mmH compatible with: MegaGen AnyRidge Implant System 30 Multi-Unit Abut. 6.5 mmH compatible with: MegaGen AnyRidge Implant System Multi-Unit Abut. 3 mmH compatible with: MegaGen AnyRidge Implant System 30 Multi-Unit Abut. 3.5 mmH compatible with: MegaGen AnyRidge Implant System 17 Multi-Unit Abut. 3.5 mmH compatible with: MegaGen AnyRidge Implant System 30 Multi-Unit Abut. 5.5 mmH compatible with: MegaGen AnyRidge Implant System Multi-Unit Abut. 4 mmH compatible with: MegaGen AnyRidge Implant System 17 Multi-Unit Abut. 4.5 mmH compatible with: MegaGen AnyRidge Implant System 30 Multi-Unit Abut. 4.5 mmH compatible with: MegaGen AnyRidge Implant System Multi-Unit Abut. 2 mmH compatible with: MegaGen AnyRidge Implant System 17 Multi-Unit Abut. 5.5 mmH compatible with: MegaGen AnyRidge Implant System Preparation Balloon SAVI Spacer Preparation Balloon SAVI Prep Device Xi Conductive Reducer - 470381 Xi Reducer (12-8mm), (470381-04, 05, 06, 07, 08, 09) Xi Ports Seal (12mm & Stapler), (470380-04, 05, 06, 07) Si Stapler Sheath - 410370 Xi Stapler 45 Reload (Blue) - 48645B Xi Seal (12mm & Stapler) - 470380 12 mm & Stapler Cannula Seal - 470380 Xi Stapler 45 Reload (White) - 48645W Xi Stapler 45 Reload (Green) - 48445G VAC WhiteFoam Large Dressing w/ SensaTRAC VAC WhiteFoam Small Dressing w/ SensaTRAC VAC WhiteFoam Large Dressing (foam only) VAC WhiteFoam Small Dressing (foam only) ActiVAC, 5 Pack KCI VAC GRANUFOAM LARGE BRIDGE DRESSING 5 PACK ASSY, 10 PACK V.A.C. 3M TEGADERM DRAPE Inclusive® Mini Implant with O-Ball 2.2 mmD x 13 mmL Inclusive® Mini Implant with O-Ball 2.5 mmD x 15 mmL Inclusive® Mini Implant with O-Ball 2.2 mmD x 10 mmL Inclusive® Mini Implant with O-Ball 2.5 mmD x 10 mmL Inclusive® Mini Implant with O-Ball 3 mmD x 13 mmL Inclusive® Mini Implant with O-Ball 3 mmD x 10 mmL Inclusive® Mini Implant with O-Ball 2.2 mmD x 15 mmL Inclusive® Mini Implant with O-Ball 3 mmD x 15 mmL Inclusive® Mini Implant with O-Ball 2.5 mmD x 13 mmL Implantium implant, endosseous, root-form Implantium and SuperLine FREEDOM STERILE FLUID PATH (SFP) CANISTER ASSY, W/GEL, 10 PK FREEDOM STERILE FLUID PATH (SFP) CANNISTER ASSY, W/GEL 5 PK Superline Superline II Stopcock FlowTriever Catheter Eye Spear, 5 pack, compressed ML110C Eye Spear, 10 pack, compressed ML100 Instrument Wipe ML115 PVA EyeSpear Eye Spear, 3 pack, expanded ML110 Manuka Honey/Tube .5oz Manuka Honey/Tube 1.5oz SenoMark, 12G, ATEC SenoMark, 10G, EnCor SenoMark, Mammotome, Titanium 10GA EnCor UltraCor MRI, TI, ¿X¿ SenoMark, 9G, ATEC SenoMark EnCor, 7G, SS UltraCor MRI, SS, ¿M¿ SenoMark 9G Eviva SenoMark EnCor, 10G, SS SenoMark EnCor, 12G, SS SenoMark, 9G, Titanium, ATEC Dental Implants Inclusive Tapered Dental Implants Trinica Parallax T-Grip Access Needle KP-TGN-1101-02 DRILL BITS Accesory Porta Kit Access Tool, Cannulated Drill NanoTack Drill Bit CinchLock Drill Bit NanoTack Flex Drill Bit OVERDRILL FOR 2MM SCREWS W/AO QC 2MM DRILL LONG W/AO QC 1.8MM DRILL SHORT W/AO QC 2MM DRILL SHORT W/AO QC 1.5MM DRILL LONG WITH AO QC OVERDRILL FOR 2.4MM SCREWS W/ AO QC ToggleLoc System VLP MINI-MOD 1.5MM OVERDRILL MINI QC MEDTRONIC Facet Screw Instruments JETX 4.8 SHT GRAD STEP DRILL 1.8MM DRILL LONG W/AO QC SpineDriver 2mm bits OVERDRILL FOR 2.7MM SCREWS W/AO QC 14" Guidewire Accessory Portal Kit Quattro Drills ACL Disposable Kit Quattro Bolt Accessory Drill Kits BioWick Drill Kits SureLock Drills Facet Screw Insruments SIGMA HP TROCHLEA CUTTING BIT 3910-075-502;3910-075-652;3910-075-802;3910-090-502;3910-090-652;3910-090-802;0234-020-175 Comprehensive Mini Baseplate Flow-Drill Comprehensive Standard Baseplate Comprehensive Augmented Glenoid Components TOGGLELOC PUSHER CAT02974 CAT02644 VertecoR Bone Drill 3 Kypho Pak Tray DISPOSABLE DRILL TIP MONOJECT 12mL Syringe, Softpack Urine Sample Preservation Tablet, Boric Acid Multi-Unit Abut. 2 mmH compatible with: NobelReplace WP 17 Multi-Unit Abut. 2 mmH compatible with: NobelReplace NP Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 3.4 mm Multi-Unit Abut. 3 mmH compatible with: NobelReplace WP 17 Multi-Unit Abut. 2 mmH compatible with: NobelReplace RP 17 Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 3.4 mm 17 Multi-Unit Abut. 3 mmH compatible with: NobelReplace RP 17 Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 5 mm Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 4.1 mm 30 Multi-Unit Abut. 4 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 2 mmH compatible with: NobelReplace NP 17 Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 5 mm 30 Multi-Unit Abut. 5 mmH compatible with: NobelReplace RP Multi-Unit Abut. 1 mmH compatible with: NobelReplace RP Multi-Unit Abut. 1 mmH compatible with: NobelReplace NP 17 Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 4.1 mm 30 Multi-Unit Abut. 4 mmH compatible with: NobelReplace RP 17 Multi-Unit Abut. 4 mmH compatible with: NobelReplace RP 30 Multi-Unit Abut. 5 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 1 mmH compatible with: Biomet 3i Certain 3.4 mm Multi-Unit Abut. 2 mmH compatible with: NobelReplace RP 17 Multi-Unit Abut. 3 mmH compatible with: NobelReplace NP Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 3.4 mm Multi-Unit Abut. 1 mmH compatible with: NobelReplace WP Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 5 mm Multi-Unit Abut. 1 mmH compatible with: Biomet 3i Certain 5 mm Multi-Unit Abut. 3 mmH compatible with: NobelReplace NP 17 Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 3.4 mm Multi-Unit Abut. 5 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 5 mmH compatible with: NobelReplace RP Multi-Unit Abut. 3 mmH compatible with: NobelReplace RP Multi-Unit Abut. 1 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 5 mm 17 Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 4.1 mm 1000 ML INFOVAC CANISTER, W/GEL, 5 PACK Enspire Vacuum Tubing Cassette Enspire Vacuum and Rinse Tubing Cassette StarchMark, 7G EnCor, SS ¿V¿ SenoMark UltraCor, SS ¿V¿ StarchMark EnCor, 10G, SS StarchMark Mammotome, 11G, SS ACIST CVi® BT2000 Manifold Kit, ACIST CVi® AngioTouch® Kit AT P65 , ACIST CVi® AngioTouch® Kit AT P54, ACIST CVi® Contra VAC INSTILL IRRIGATION TUBING - 5 PACK KCI TRAC DRESSING, LARGE FOAM, 10 PACK, EE HEEL DRESSING ASSEMBLY W/SENSATRAC, 5 PACK KCI TRAC DRESSING, SMALL FOAM, 10 PACK KCI TRAC DRESSING, MEDIUM FOAM, 10 PACK, EE SENSATRAC, THIN VAC GRANUFOAM DRESSING 5 PACK KCI TRAC DRESSING, MEDIUM FOAM, 5 PACK, EE KCI SENSA TRAC GRANUFOAM MEDIUM SPIRAL DRESSING, 10PK VAC GRANUFOAM SILVER SMALL DRESSING - 10 PACK KCI TRAC DRESSING, LARGE FOAM, 5 PACK, EE VAC GRANUFOAM LARGE BRIGDE DRESSING USING THE 10 PACK VAC DRAPE, 10-PACK, EE SENSATRAC, ROUND GRANUFOAM DRESSING 10 PACK KCI TRAC DRESSING, SMALL FOAM, 5 PACK, EE KCI DIABETIC FOOT ULCER [DFU] - 5 PACK KCI ABDOMINAL DRESSING ASSEMBLY W/SENSATRAC, 5 PACK KCI DIABETIC FOOT ULCER [DFU] - 10 PACK KCI ABDOMINAL DRESSING ASSEMBLY W/NON-ADHERENT LAYER, 5 PACK VAC INSTILL IRRIGATION PAD - 5 PACK VAC INSTILL IRRIGATION - 5 PACK OPEN ABDOMINAL DRESSING, 5-PACK KCI SENSA TRAC GRANUFOAM SMALL SPIRAL DRESSING, 5PK VAC GRANUFOAM SILVER MEDIUM DRESSING - 10 PACK KCI VERSA (SOFT WHITE) FOAM TRAC DRESSING SUB-ASSEMBLY KCI TRAC DRESSING, SMALL FOAM, 10 PACK, EE KCI SOFT WHITE FOAM TRAC DRESSING SUB-ASSEMBLY KCI SENSA TRAC GRANUFOAM MEDIUM SPIRAL DRESSING, 5PK VAC GRANUFOAM SILVER LARGE DRESSING - 10 PACK VAC X-LARGE GRANUFOAM DRESSING (EASTERN EUROPE), 5 PACK KCI STAND ALONE TRAC PAD ASSY 10 PACK, EE VAC DRAPE, 10-PACK HEEL DRESSING ASSEMBLY, 5 PACK KCI SENSA TRAC GRANUFOAM SMALL SPIRAL DRESSING, 10PK Multi-Unit Abut. 1.5 mmH compatible with: Ankylos /X Multi-Unit Abut. 2.5 mmH compatible with: Ankylos /X Multi-Unit Abut. 4.5 mmH compatible with: Ankylos /X Multi-Unit Abut. 3.5 mmH compatible with: Ankylos /X Universal Seal (5-12mm) - 470500 VAC GRANUFOAM SILVER LARGE DRESSING WITH SENSATRAC - 10 PK INFOVAC CAN ASSY, W/ GEL, 5 PK Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 5 mm Multi-Unit Abut. 1 mmH compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abut. 1 mmH compatible with: Camlog Screw-Line 4.3 mm Multi-Unit Abut. 1 mmH compatible with: Camlog Screw-Line 5 mm 17 Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abut. 5 mmH compatible with: Camlog Screw-Line 4.3 mm 30 Multi-Unit Abut. 5 mmH compatible with: Camlog Screw-Line 4.3 mm 17 Multi-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 4.3 mm Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 4.3 mm 17 Multi-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 4.3 mm 30 Multi-Unit Abut. 5 mmH compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 5 mm 17 Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 4.3 mm 30 Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 3.8 mm 30 Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 4.3 mm Multi-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 3.8 mm 17 Multi-Unit Abut. 5 mmH compatible with: Camlog Screw-Line 4.3 mm 800068-006 BT2000 Manifold Kit, New Braid Tube 800069-008 B2000 Trigger No Hole AMT Manifold 800923-003 A2000V MULTIUSE SYRINGE KIT NEW WS and WI 800068-010 BT2000 Trigger No Hole AMT Manifold 800061-014 A2000 LUERLESS MULTIUSE SYRINGE KIT NEW WS and WI 800061-008 A2000 Syringe Kit, New Braid Tube 800068-009 BT2000 Manifold Kit, West Plunger 5301 800068-007 BT2000 Manifold Kit, New Transducer 800069-006 B2000 Manifold Kit, New Braid Tube 800923-002 ASSEMBLY A2000V 800068-016 BT2000 MANIFOLD KIT, QURE PLUNGER 800061-016 A2000, CV2 Barrell 800068-008 BT2000 NHB Manifold 800068-011 BT2000 Alternative Material, Manifold Kit 800069-009 B2000 Alternative Material, Manifold Kit 800923-001 Assembly A2000V A2000 Multi-use Syringe Kit, A2000V Multi-use Syringe Kit, B/BT2000 Automated Manifold Kit Endovascular Embolization Coil; Syringe Kit MicroPlex; HydroCoil; HydroLink VASCADETM 6/7F Vascular Closure System VASCADETM 5F Vascular Closure System VASCADE MVP VASCADE 6/7F VASCADETM MVP Venous Vascular Closure System VASCADE 5F VASCADE MVPTM 6-12F Venous Vascular Closure System VASCADETM MVP XL Venous Vascular Closure System Assy, 9GA SenoCor 360 Trocar Tip Device ASSY, KCI PREVENA DRESSING, 5-PACK ASSY, KCI PREVENA CANISTER, BULK PACK (26 PCS) ASSY, KCI PREVENA DRESSING, BULK PACK Stopcock 3 Way 3-Way Stopcock Hahn™ Tapered Implant Healing Abutment 3 mmH - 05 Implant Hahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 03 Implant Hahn Tapered Implant Multi-Unit Abut. 4.5 mmH - 05 Implant Hahn™ Tapered Implant 04.3 x 13 mm Hahn™ Tapered Implant 05 x 11.5 mm Hahn Tapered Implant 17 Multi-Unit Abutment 3.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abut. 3.5 mmH - 03 Implant Hahn Tapered Implant Multi-Unit Abut. 2.5 mmH - 05 Implant Hahn™ Tapered Implant 07 x 11.5 mm Hahn™ Tapered Implant 03.5 x 13 mm Hahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 05 Implant Hahn™ Tapered Implant Healing Abutment 3 mmH - 03 Implant Hahn Tapered Implant 17 Multi-Unit Abut. 3.5 mmH - 05 Implant Hahn Tapered Implant Multi-Unit Abut. 1.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant Healing Abutment 7 mmH - 03 Implant Hahn™ Tapered Implant Healing Abutment 5 mmH - 03.5 Implant Hahn Tapered Implant Multi-Unit Abutment 4.5 mmH - 05 Implant Hahn™ Tapered Implant 04.3 x 8 mm Hahn™ Tapered Implant 03 x 13 mm Hahn Tapered Implant 30 Multi-Unit Abutment 4.5 mmH - 05 Implant Hahn Tapered Implant 17 Multi-Unit Abut. 2.5 mmH - 05 Implant Hahn Tapered Implant 17 Multi-Unit Abut. 2.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant 05 x 16 mm Hahn™ Tapered Implant 03 x 16 mm Hahn Tapered Implant Multi-Unit Abut. 1.5 mmH - 05 Implant Hahn Tapered Implant Multi-Unit Abut. 3.5 mmH - 05 Implant Hahn™ Tapered Implant 05 x 8 mm Hahn Tapered Implant 30 Multi-Unit Abut. 4.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abutment 1.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant 30 Multi-Unit Abut. 3.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant 07 x 8 mm Hahn™ Tapered Implant 04.3 x 10 mm Hahn Tapered Implant 30 Multi-Unit Abut. 4.5 mmH - 05 Implant Hahn™ Tapered Implant 03 x 11.5 mm Hahn™ Tapered Implant Healing Abutment 7 mmH - 05 Implant Hahn™ Tapered Implant 03.5 x 11.5 mm Hahn™ Tapered Implant 03.5 x 10 mm Hahn Tapered Implant 30 Multi-Unit Abutment 3.5 mmH - 05 Implant Hahn™ Tapered Implant Healing Abutment 3 mmH - 07 Implant Hahn Tapered Implant 30 Multi-Unit Abutment 4.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant 30 Multi-Unit Abut. 3.5 mmH - 05 Implant Hahn Tapered Implant Multi-Unit Abut. 3.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant 17 Multi-Unit Abutment 2.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abut. 2.5 mmH - 03.5/4.3 Implant Hahn Tapered Implant 17 Multi-Unit Abutment 2.5 mmH - 05 Implant Hahn™ Tapered Implant 04.3 x 11.5 mm Hahn™ Tapered Implant 07 x 10 mm Hahn™ Tapered Implant Healing Abutment 5 mmH - 07 Implant Hahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant Healing Abutment 5 mmH - 04.3 Implant Hahn™ Tapered Implant Healing Abutment 5 mmH - 05 Implant Hahn Tapered Implant 17 Multi-Unit Abut. 3.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant Healing Abutment 3 mmH - 03.5 Implant Hahn™ Tapered Implant 03.5 x 16 mm Hahn™ Tapered Implant Healing Abutment 7 mmH - 03.5 Implant Hahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 05 Implant Hahn™ Tapered Implant Healing Abutment 3 mmH - 04.3 Implant Hahn Tapered Implant 17 Multi-Unit Abutment 3.5 mmH - 05 Implant Hahn™ Tapered Implant Healing Abutment 5 mmH - 03 Implant Hahn™ Tapered Implant 04.3 x 16 mm Hahn Tapered Implant Multi-Unit Abut. 2.5 mmH - 03 Implant Hahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 03 Implant Hahn Tapered Implant Multi-Unit Abutment 1.5 mmH - 05 Implant Hahn™ Tapered Implant Healing Abutment 7 mmH - 04.3 Implant Hahn™ Tapered Implant 05 x 10 mm Hahn Tapered Implant 30 Multi-Unit Abutment 3.5 mmH - 03.5/4.3 Implant Hahn™ Tapered Implant 03.5 x 8 mm Hahn™ Tapered Implant 05 x 13 mm Xi Optical Obturator (12mm & Stapler, Standard), (470403-01 &-02) Xi Optical Obturator (12mm & Stapler, Long), (470404-01 & -02) Xi Optical Obturator (8mm, Standard), (470359-01 &-02) Xi Optical Obturator (8mm, Long), (470360-01 &-02) Xi Optical Obturator (12mm & Stapler, Standard) - 470403 8 mm Bladeless Obturator - 470359 Xi Optical Obturator (12mm & Stapler, Long) -470404 Xi Optical Obturator (8mm, Standard) - 470359 Xi Optical Obturator (8mm, Long) - 470360 8 mm Bladeless Obturator, Long - 470360

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2013-02-26
KNY Accessories, Catheter, G-U Gastroenterology, Urology Class 2 876.5130 2012-10-30
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2016-02-25
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2012-10-30
KYF Implant, Eye Valve Ophthalmic Class 2 886.3920 2017-01-18
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-10-30
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-10-30
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-03-05
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-02-26
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-06-23
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2013-02-27
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2016-11-16
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2019-08-15
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2025-02-25
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2017-06-19
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-10-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-06-23
OGO Intraocular Pressure Lowering Implant Unknown Class 3 N/A 2013-02-26
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-06-23
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2013-02-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-03-05
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2017-07-05
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2017-07-05
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-10-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-06-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-26
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-10-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-06-22
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2019-08-15
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2019-08-15
HOZ Sponge, Ophthalmic Ophthalmic Class 2 886.4790 2013-02-26
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-02-26
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2013-02-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-26
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-11-01
FMF Syringe, Piston General Hospital Class 2 880.5860 2012-10-24
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2016-11-16
JXA Kit, Screening, Urine Microbiology Class 1 866.2660 2013-02-27
HAB Saw, Powered, And Accessories General, Plastic Surgery Class 1 878.4820 2013-02-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-06-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-06-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-06-22
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-10-30
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2021-06-22
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-02-26
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2013-02-27
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2019-08-15
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-10-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-06-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-02-09
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-10-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-06-23
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2017-06-19
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2013-02-26
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2014-01-30
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2013-02-27
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-10-30
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-06-23
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2013-02-26
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-06-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-06-22
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2021-06-22
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2021-06-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-07-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-06-23

Official Correspondent

Karen Whaley-Krumins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sotera Health LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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
K951256 Target Therapeutics DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) 1995-09-08
K873288 Todd Medical, Inc. CLOSED FOLEY CATHETER SYSTEM 1987-11-27
K912919 Mentor Corp. MENTOR INFUSION LINE 1991-12-13
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2013 Accuro Medical Product LLC 2
Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015 Smith & Nephew, Inc. 2
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015 Smith & Nephew, Inc. 2
RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015 Smith & Nephew, Inc. 2
RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0007-2017 Baxter Corporation Englewood 2
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

Similar Registrations

Registration Number Establishment Name Location
9615728 BIOSPHERE MEDICAL, S.A. Roissy Val-d'Oise, FR
2029275 Sterigenics U.S., LLC Corona, CA, US
3008853977 Stryker Neurovascular Fremont, CA, US
1721676 Sterigenics U.S., LLC Salt Lake City, UT, US
3015550451 MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Irvine, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2022435. Last updated year: 2026. Please use registration number 2022435 when referencing this establishment in official correspondence.
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