Sterigenics U.S., LLC

FDA Device Registration & Listing · Haw River, NC, US · Registration 1036836

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
1036836
FEI Number
1036836
Entity Name
Sterigenics U.S., LLC
City/State/Country
Haw River, NC, US
Establishment Address
1148 Porter Ave, Haw River, NC 27258, 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

CERTAIN® MICROMINI FLAT IMPLANT COVER SCREW CERTAIN® IMPLANT HEADLESS COVER SCREW CERTAIN® FLAT IMPLANT COVER SCREW Graftgun Universal Graft Delivery System - Additional Graft Tube Graftgun Universal Graft Delivery System - Additional 5cc Grafgun Tube Slide Fix Jars VIAL W/CAP 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 SLM , Wallace ENDOTINE TRANSBLEPH ENDOTINE TRIPLE MBA Subtalar Implant System MBA Titanium Subtalar Implant System Integra Kompressor Compression Screw System ENDOTINE FOREHEAD ENDOTINE MIDFACE B ENDOTINE MIDFACE-ST Kompressor Compression Screw System Guide Pin 2.4 x 508 R/R Package ASM, No. 300-1011 DS Portal Tube Package ASM, No. 550-0013 Guide Pin 2.4 x 508 T/R Package ASM, No. 300-1010 Guide Pin 1.1 x 635 Package ASM, No. 430-0041 Portal Tube Package ASM, No. 315-0016 StabiliT Introducer 3.6-11.5-EB 42-3100 FlexDex Needle Driver StabiliT Delivery Instruments, Short StabiliT Introducer 3.6-11.5-ED INSTRUMENT, MANUAL, SURGICAL, GENERAL USE DermaBlade® 2.4MM ARTHROSCOPY KNIFE, BANANA STYLE, SMALL JOINT, 4 EA StabiliT Introducer 3.6-D StabiliT Delivery Instruments, Long HIGH STRENGTH BREAKAWAY GUIDE PIN, 12 IN, STERILE, 2.4 X 305MM (93 X 12IN) StabiliT Introducer 3.6-B Locking Delivery Cannula 3-11.5-ED HIGH STRENGTH BREAKAWAY GUIDE PIN, 9 IN, STERILE, 2.4 X 229MM (93 X 9IN) 45 DEGREE BLITZ SUTURE RETRIEVER, LEFT, 6 EA Spineology Guide Pin Catalog# 300-1011 Locking Delivery Cannula 3 Spineology Guide Pin Catalog# 530-0089 Spineology Guide Pin Catalog# 530-0088 Spineology Guide Pin Catalog# 430-0041 Spineology Guide Pin Catalog# 530-0087 2.4MM ARTHROSCOPY KNIFE, SMILLIE, SMALL JOINT, QTY 4 BIOSCREW HYPERFLEX GUIDEWIRE, NITINOL, 14 IN, STERILE, 0.8 X 356MM (32 X 14IN) SE GRAFT TENSIONER BREAKAWAY PINS WITH GRAFT TENSION CALCULATOR, QTY 5 ARTHROSCOPY KNIFE, RETROGADE, SMALL JOINT, 2.4mm, QTY 4 45 DEGREE BLITZ SUTURE RETRIEVER, RIGHT, 6 EA Spineology Diverted Fill Tube Catalog# 300-0009 SUTURE SAVER KIT, QTY 5 Spineology Guide Pin Catalog# 300-1010 MedOne Guide Pin 2.4 x 508 T/R Package ASM, #300-1010 Guide Pin 1.1 x 635 Package ASM, #430-0041 Yankauer Suction Device DS Portal Tube Package ASM, # 550-0013 Portal Tube Package ASM, # 315-0016 NM Dilator One, #315-0012 DermaBlade Guide Pin 2.4 x 508 R/R Package ASM, #300-1011 Trocar Cleaner - XL 12 mm SurgiSlush Sleeve (1011) LipiFlow ®System Activator (Disposable) LipiFlow ®System Activator (Disposable) PROVIDE® IMPRESSION COPING WITH HOLES 4.8MM(P) - 4MM POST PROVIDE® IMPRESSION COPING 4.8MM(P) - 5.5MM POST DRILL STOP, 2.3MM-3.25MM X 15MM PROVIDE® IMPRESSION COPING 6.5MM(P) - 5.5MM POST DRILL STOP, 4.25MM-5.25MM X 18MM PROVIDE® IMPRESSION COPING WITH HOLES 4.8MM(P) - 5.5MM POST DRILL STOP, 4.25MM-5.25MM X 8.5MM CONICAL EP® TWIST LOCK TM COPING MPLANT EP® PICK-UP COPING CERTAIN® EP® TWIST LOCK TM COPING Disposable Countersink Drill Index Coping - Surgical Disposable Pilot Drill CERTAIN® HEX TRY-IN SCREW CERTAIN® STRAIGHT PICK UP COPING CERTAIN® PICK-UP COPING Disposable Drill Kit Drill Kit Tapered CONICAL EP® PICK-UP COPING (HEXED) IMPLANT EP® TWIST LOCK TM COPING Disposable Round Drill Drill Kit Parallel Walled IMPLANT EP® PICK-UP COPING CERTAIN® STRAIGHT PICK-UP COPING Standard Abutment Transfer Coping Standard Abutment Pick-Up Coping CERTAIN® TWIST LOCK TM STRAIGHT TRANSFER COPING CONICAL EP® PICK-UP COPING (NON-HEXED) Disposable Twist Drill, Non-Hubbed Pick-Up Impression Coping Conical Abutment Pick-Up Coping Disposable Twist Drill PROVIDE® IMPRESSION COPING 4.8MM(P) - 4MM POST PROVIDE® IMPRESSION COPING WITH HOLES 6.5MM(P) - 4MM POST DRILL STOP, 4.25MM-5.25MM X 13MM PROVIDE® IMPRESSION COPING WITH HOLES 6.5MM(P) - 5.5MM POST DRILL STOP, 2.3MM-3.25MM X 10MM DRILL STOP, 2.3MM-3.25MM X 20MM PROVIDE® IMPRESSION COPING 6.5MM(P) - 4MM POST Grieshaber 45° Dela mination Spatula DSP 23 Ga Grieshaber 45° Pic DSP 25 Ga Hook, Ophthalmic Grieshaber 45° Pic DSP 23 Ga Grieshaber 45° Delamination Spatula DSP 25 Ga Grieshaber 45 degree Delamination Spatula DSP 25 Ga Grieshaber 45 degree Delamination Spatula DSP 23 Ga Grieshaber 45 degree Pic DSP 23 Ga Grieshaber 45 degree Pic DSP 25 Ga 25+™ FINESSE™ Flex Loop DSP 23G FINESSE(TM) Flex Loop DSP 23G FINESSE™ Flex Loop DSP GRIESHABER ™ 45° Delamination Spatula DSP 25G GRIESHABER™ 45° Pic DSP 25G 27+™ FINESSE™ Flex Loop DSP GRIESHABER™ 45° Pic DSP 23G GRIESHABER™ 45° Delamination Spatula DSP 23G LDA Screw SBL Hemospray Hemospray Endoscopic Hemostat LDA Screw NBA Robotips (1006) QUICKBRIDGE TM CYLINDER AND CAP QUICKBRIDGE TM CAP Beaver Skinceuticals Dermaplane Blade Defogger (various) DeFogger Dish, Tissue Culture 17240/48 17651/100 PETRI60X15/100 Slide Permanox 384 Shallow Well, Standard Height, CC Black Italy Nunclon OmniTray Barcode Pre-Assembled CF-10 w/TS Novartis 992, 384W Plate, w/BC 384 Shallow Well, Standard Height, CC White 384 Well, White, CC Treat Skin Graft Growth Dish 1536 Shallow Well, Standard HT CC Black, w/Lid Cell Factory 1 Chamber 632 CM2 225cm2 Easy Flask, Vent 384 Well, Black, CC Treat 1536 Shallow Well, Standard HT CC White, w/Lid 1536 Shallow Well, Standard HT CC Clear, w/Lid Barcoded 384W OBP, Black, CC, GSK 384 OBP, Black, CC Treat, w/Lid Cell Fact 10 Chamber 6,320 CM2 384 OBP Coverglass, Black, CC, w/Lid 150x15mm TC Dish w/Vents 384 Shallow Well, Standard Height, CC Clear 384 OBP Coverglass, Black, CC, w/Lid Sample Cell Factory 10 Chamber 6,320 CM2 225cm2 Easy Flask, Filter 384 Well, Clear, CC Treat Omnitray, CC Treat, Ster, w/Lid EasyFill CF Adapt Port Cap, ½ 35 x 10mm Suspension Dish 96 Well OBP, TCC, Black Pre-Assembled CF-40, Novartis EasyFill CF ¼ 4 Well Dish Nunclon Strl, Lid 35 x 10mm TC Dish w/2mm Grid EasyFill, CF 3/8 Cell Factory 2 Chamber 1,264 CM2 384 Well Plate, PS, White w/o lid, CC treated CelBio, OmniTray, Nunclon,n D-BC-S1&2 384 Well Plate, Black w/o Lid Cell Factory 40 Chamber 25, 280cm Skin Graft Growth Dish with Lifter 384 OBP, Black, CC Treat, w/o Lid 384 White CC w/2 barcode labels 96 OBP Polymer Black CC w/Lid 384 Well Plate w/barcode labels 8 Well Dish Nunclon Stel, Lid 60 x 15mm TC Dish Permanox 96 OBP Polymer White CC w/Lid CERTAIN® PREFORMANCE® POST CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT CERTAIN® GINGHUE TM ANGLED POST STANDARD ABUTMENT TEMPORARY SCREW TEMPORARY HEXED CYLINDER CERTAIN® EP® HEALING ABUTMENT GINGIHUE® PRE-ANGLED POST TEMPORARY HEALING RETENTION CYLINDER CERTAIN® GINGIHUE® PRE-ANGLED POST CONICAL HEALING CAP CERTAIN® GINGIHUE® ANGLED POST CERTAIN® STRAIGHT HEALING ABUTMENT GINGIHU+C4:C33E® POST CERTAIN® PREFORMANCE® PRE-ANGLED POST CERTAIN® GINGIHUE® POST TEMPORARY HEXED CYLINDER WITH RETENTION PREP-TITE® POST WITH TI HEXED SCREW EP® HEALING ABUTMENT GOLD-TITE® HEXED RETAINING SCREW HEALING ABUTMENT CERTAIN® TEMPORARY HEXED CYLINDER TEMPORARY NON-HEXED CYLINDER WITH RETENTION MONOJECT 12mL Syringe, Softpack Titanium Hexed Screw Prep-Tite Post Marker Pads and Marker Pens Surgical Marker, Ophthalmic 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) CERTAIN® PREFORMANCE® POST CERTAIN® PREFORMANCE® PRE-ANGLED POST 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 TSV™ BELLATEK® ENCODE® HEALING ABUTMENT LDA SCREW NBR OLL OUS RGE TER TAB Spatula, Ophthalmic (multiple brands) Spatula, Ophthalmic EndoSerter ES-1 COPS1 HS10F 200CS01 COPH10 CST-H10 HLS10LT 212CS20 HST10F CST-H1 COP-MIN 200CS10 229CS01 223CS20 HS1F CST-S10 200CS05 224CS20 COP-NED HLH1ST HS1R 201CS10 CT50-S1 212CS05 INFS10 HLS10ST HLT10R 201CS01 BIOASSAY DISH, LOW PROFILE PS COPTS-5 COPTS-10 INFH1 212CS01 HST10R HLT10F HLS1ST INF-NED HST1F CD179S01 CD178S01 COPH1 HS10R CST-NED 224CS01 CD177S01 CST-S1 209CS20 COPTS-01 201CS20 HLT1R HLNEDLT CT50-H1 CT50-S10 202CS01 COPS10 HLT1F 218CS20 222CS10 COPTS10ZL 223CS01 HLS1LT 202CS20 HST1R INFH10 INFS1 200CS30 HSTND HSND 222CS01 HLNEDST Multidex Gel (various) Sterile Multiple Puncture Device Algidex™ Packing Strips Algidex (various) Algidex AG Algidex Packing Strips Algidex Gauze Algidex Thin Film PREFORMANCE® POST PREFORMANCE® TEMPORARY CYLINDER (NON-HEXED) PREFORMANCE® TEMPORARY CYLINDER (HEXED) PREFORMANCE® PRE-ANGLED POST Specula, Ophthalmic Flask, Baffled, PETG Disposable PETG Flask, Baffled Bottom, 2800ml, Standard Closure Disposable PETG Flask, Plain Bottom, 2800ml, Vented Closure Vented Sterile Disposable Flask 07 0010 Samco™ Bio-Tite™, 90mL, Midstream Kit with Funnel 02 0016 Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap 02 0002 Cardinal Health™ Specimen Container, 90mL/48mm, ORG Cap container, specimen, sterile Vacuette No -Additive Tubes Clikseal Portex Speciman Trap Midstream Kit (Container Specimen) Pathology Container, Snap Cap, PN 0480-1101 Pathology Container, Snap Cap, PN 0450-1101 Pathology Container, Snap Cap, PN 0450-1111 1008/100 1002/36 Pathology Container, Snap Cap, PN 0501-1101 19227/12 B0810/50 Pathology Container, Snap Cap, PN 0480-1111 B0612/100 17531/50 B1708/50 TP002/50 1060/50 1050/50 PSS001/25 TP0014/50 B2923/50 B1212/25 17511/20 1005W/25 B1706/50 MHBFK01/10 JBQ773 1004/36 17531/20 PDC001/20 KB006L/20 B1111Z/25 B1912/100 B1710/100 1055/50 B1115Z/50 B0633/50 1013/100 1007/50 1070/50 SSB001/10 17555/50 B0606/25 BCP300/100 B0652/10 TP0015/50 17511C/20 TP0016/50 TP003/200 1001R/36 1055/75 SJMC001/10 B1215/100 Catch Kit: 25000 Speciman Cup: 8889207026 Corning Cryogenic vials and accessories Speciman Collection: 2600SA Catch Kit: 22000 Speciman Collection: 2090SA 430490 430661 430489 Speciman Container: 15000 Speciman Collection: 2205SA 431422 Speciman Collection: 2040SA Catch Kit: 22015 430663 430658 Speciman Collection: 2300SA Catch Kit: 25015 Speciman Collection: 2210SA 430659 430179 352001 Speciman Cup: 8889207067 Speciman Collection: 4090SA Speciman Container: 45117 Speciman Collection: 17099 Speciman Collection: 2200SA 352045 352006 Speciman Container: 14999 Speciman Container: 14000 431421 354015 Speciman Collection: 2650SA 352003 430488 Vitronova 431386 430487 430491 431418 430656 352037 431458 430492 354013 431420 431417 431419 430662 90ORG53-1001 90ORG53-1000 90WHT53-1000 SAMCO 90mL/53mm CLK SPC LBL WT CAP ST 5000-0020 Nalgene™ Cryogenic Tube, 2 mL externally-threaded 5005-0015 Nalgene™ Specimen Cryogenic Vial, 15 mL externally-threaded 02 1090 Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, ORG Cap 90WHT53-1001 Samco™ Clicktainer™ Vial, WHT Cap, 90mL, 53mm, w/lab, temp strip, ST 90ORG53-1000 Samco™ Clicktainer™ Vial, ST, 90mL, 53mm, w/lab, ORG Cap 07 0002 Samco™ Bio-Tite™, ST, 120mL, 53mm Midstream Kit No Funnel 03 0006 Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, ORG Cap 07 0001 Samco™ Bio-Tite™, ST, 90mL, 48mm Midstream Kit with Funnel 22-2090 Samco™ Bio-Tite™ Wide Mouth, ST, 90mL, 53mm, w/lab, YEL Cap 02 1016 Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, WHT Cap 120WHT53-3000 Samco™ Clicktainer™ Vials, ST, 120mL, 53mm, Midstream Kit, no fnl 01 0001 Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, w/lab, ORG Cap CHB13905 Cardinal HealthTM Specimen Container, O/R Pouch 120mL/53mm 120ORG53-1000 Samco™ Clicktainer™ Vials, ST, 120mL, 53mm, w/lab, ORG Cap 90ORG53-1001 Samco™ Clicktainer™ Vial, ST, 90mL, 53mm, w/lab, ORG Cap, dsp box 5005-0015 Nalgene™ Specimen Cryogenic Vial, 15 mL externally-threaded 02 0002 Cardinal HealthTM Specimen Container, 90mL/48mm, ORG Cap 01 0002 120ml/53mm SPCw/LBL, WH CAP,ST 02 0039 Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, WHT Cap 120ORG53-4000 Samco™ Clicktainer™ Vials, ST, 120mL, 53mm, O/R Pouch, ORG Cap 02 1038 Samco™ Bio-Tite™ Wide Mouth, ST 90mL, 53mm, w/lab, Natural Cap 02 0214 Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap, dsp box CHB13904 Cardinal HealthTM Specimen Container 120mL/53mm 90WHT53-1000 Samco™ Clicktainer™ Vial, ST, 90mL, 53mm, w/lab, WHT Cap 120ORG53-4000 22 610 131 Fisherbrand™ 60mL, 48mm, ST, w/lab and temp strip, WHT Cap 120WHT53-4000 03 0008 Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, Green Cap 07 0020 Samco™ Bio-Tite™, 120ml, Midstream Kit, no funnel CHB13903 Cardinal HealthTM Specimen Container 90mL/53mm 5000-0050 Nalgene™ Cryogenic Tube, 5 mL externally-threaded 01 0038 Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, w/lab, NAT Cap CHB13902 Cardinal HealthTM Specimen Container 90mL/48mm 120WHT53-1000 Samco™ Clicktainer™ Vials, ST, 120mL, 53mm, w/lab, WHT Cap 07 0000 Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, no lab, ORG Cap 90WHT53-1002 Samco™ Clicktainer™ Vial, ST, 90mL, 53mm, w/temp strip, WHT Cap 90GRN53-1000 Samco™ Clicktainer™ Vial, ST, 90mL, 53mm, w/lab, GRN Cap 03 0007 Samco™ Bio-Tite™ Narrow Mouth, ST 60mL, 48mm, w/lab, WHT Cap 02 0038 Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, Natural Cap 120WHT53-4000 Samco™ Clicktainer™ Vials, ST, 120mL, 53mm, O/R Pouch, WHT Cap 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 CERTAIN® PREFORMANCE® TEMPORARY CYLINDER (NON-HEXED) CERTAIN® PREFORMANCE® TEMPORARY CYLINDER (HEXED) PIVO 27+(TM) REVOLUTION DSP Straight Scissors Scissors, Ophthalmic REVOLUTION DSP 25 Ga+ Curved Scissors 27+(TM) Advanced DSP Tip Straight Scissors Advanced DSP Tip Curved Scissors, 25Ga+ REVOLUTION DSP Vertical Scissors Advanced DSP Tip Curved Scissors, 25Ga REVOLUTION DSP 23Ga Curved Scissors Advanced DSP Tip Curved Scissors, 23Ga REVOLUTION DSP 23Ga Vertical Scissors Scissors, ophthalmic (multiple brands) REVOLUTION DSP 23G Curved Scissors 25+™ Advanced DSP Tip Curved Scissors Advanced DSP Tip Curved Scissors, 25G 27+™ Advanced DSP Tip Straight Scissors 25+™ REVOLUTION DSP Curved Scissors 27+™ REVOLUTION DSP Straight Scissors REVOLUTION DSP 23G Vertical Scissors REVOLUTION DSP Vertical Scissors, 1 mm REVOLUTION DSP 25G Curved Scissors Advanced DSP Tip Curved Scissors, 23G Advanced DSP Tip Curved Scissors, 20Ga REVOLUTION DSP 25Ga Curved Scissors Algidex IV Patch Kalginate Pad Laminar Flow Phaco Tip Cover Screw Headless Implant Cover Screw POWERPULSE HIP/KNEE DISP UNT W/SUCT POWERPLSE HIP/KNEE DISP UNT W/O SUC 0210-166-000 0210-210-000 0210-010-100S1 0211-110-000 0210-015-000 0210-218-000 0210-010-100 0210-918-100 0210-114-100 0210-918-000 0210-018-200 0211-100-000 0210-167-000 0210-218-100 0210-118-100 0211-214-000 0210-018-100 0210-018-000 0210-012-000 0211-118-000 0210-165-000 0210-114-100S1 0210-014-000 0210-200-000 0210-114-000S5 0210-212-000 0210-100-000 0211-112-000 0210-158-000 0210-118-200 0210-100-000S4 0210-110-000 0210-016-000 0210-112-000 0210-014-100 0211-212-000 0210-114-000 0210-058-000 0210-900-000 0210-214-000 0211-114-000 0210-010-000 0210-110-100 0210-118-000 0210-014-600 ELEFANT Bio Med wash LOCATOR® EXTENDED RANGE MALES LOCATOR® EXTRA LIGHT RETENTION MALES LOCATOR® REPLACEMENT MALES CERTAIN® LOCATOR® ABUTMENT LOCATOR® ABUTMENT LOCATOR® LIGHT RETENTION REPLACEMENT MALES LOCATOR® EXTRA LIGHT ANGLED REPLACEMENT MALE MiniStop Filter Closed Waste Basin Unit, Filter, Membrane Filter; Membrane Membrane filter unit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2016-11-01
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2012-10-31
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-03-21
FMF Syringe, Piston General Hospital Class 2 880.5860 2018-03-22
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 2012-11-16
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2013-03-21
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2012-11-15
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2013-03-21
MQH Microtools, Assisted Reproduction (Pipettes) Obstetrics/Gynecology Class 2 884.6130 2012-10-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-10-31
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2012-11-01
FPF Bottle, Hot/Cold Water General Hospital Class 1 880.6085 2024-02-09
ORZ Eyelid Thermal Pulsation System Ophthalmic Class 2 886.5200 2012-11-16
ORZ Eyelid Thermal Pulsation System Ophthalmic Class 2 886.5200 2017-06-15
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2016-11-01
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2012-11-09
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2012-11-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-03-21
PJE Blood/Plasma Collection Device For Dna Testing Clinical Chemistry Class 2 862.1675 2016-11-01
QAU Hemostatic Device For Endoscopic Gastrointestinal Use General, Plastic Surgery Class 2 878.4456 2018-06-29
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-03-21
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2013-03-21
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2012-11-16
HPL Device, Fixation, Ac-Powered, Ophthalmic Ophthalmic Class 1 886.1290 2024-02-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-03-21
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2013-03-21
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2012-10-31
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2012-10-31
OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2024-02-09
KIZ Dish, Tissue Culture Hematology Class 1 864.2240 2012-11-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-03-21
FMF Syringe, Piston General Hospital Class 2 880.5860 2012-10-24
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-03-21
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2016-11-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-03-21
HMQ Marker, Sclera Ophthalmic Class 1 886.4570 2012-11-01
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-11-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-03-21
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2013-03-21
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2012-10-31
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-11-16
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-03-21
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2012-10-31
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2012-11-01
OTZ Graft Insertion Instrument For Endothelial Keratoplasty Ophthalmic Class 1 886.4300 2012-10-31
PJE Blood/Plasma Collection Device For Dna Testing Clinical Chemistry Class 2 862.1675 2016-11-01
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2012-11-01
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2019-10-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-03-21
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2017-06-14
MQX Needle, Acupuncture, Single Use General Hospital Class 2 880.5580 2018-07-05
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2016-11-01
FRO Dressing, Wound, Drug Unknown Class U N/A 2012-10-31
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2024-02-09
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-02-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-03-21
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2012-11-01
KJA Flask, Tissue Culture Hematology Class 1 864.2240 2009-08-14
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2010-06-11
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2012-11-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-03-21
ORZ Eyelid Thermal Pulsation System Ophthalmic Class 2 886.5200 2024-02-09
ORZ Eyelid Thermal Pulsation System Ophthalmic Class 2 886.5200 2018-03-22
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2019-12-02
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2012-11-01
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2013-03-21
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2012-11-16
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2012-10-31
FRO Dressing, Wound, Drug Unknown Class U N/A 2012-10-31
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2012-11-16
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-03-21
FQH Lavage, Jet General Hospital Class 2 880.5475 2012-10-31
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-03-21
JRL Unit, Filter, Membrane Clinical Chemistry Class 1 862.2050 2012-11-16

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
K945777 Smiths Industries Medical Systems, Inc. PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES 1994-12-22
K123940 Demetech Corp. DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE 2014-05-30
K050845 ETHICON, Inc. MONOCRYL PLUS ANTIBACTERIAL SUTURE 2005-06-29
K081806 Idi Biomedical, LLC IDI IMPLANT SYSTEM 2008-11-07
K120793 Z-Systems AG Z-LOOK3 EVO SLM 2012-12-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2014 Perkin Elmer Health Sciences, Inc. 2
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0010-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1036836. Last updated year: 2026. Please use registration number 1036836 when referencing this establishment in official correspondence.
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