FDA Registration
Active
🇺🇸 United States
Sterigenics U.S., LLC
Reg #: 2245590
·
FEI: 2245590
·
Expires 2026
Products
19
Proprietary Names
285
Establishment Types
1
Classifications
19
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Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 2245590
- FEI Number
- 2245590
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 75 Tilbury Rd
- City
- Salem
- State
- NJ
- ZIP
- 08079
- Country
- US
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2018-08-31 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2012-11-13 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 2021-04-29 |
| Implant, Eye Sphere | HPZ | Class 2 | Ophthalmic | No | 2021-04-29 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2018-08-31 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2018-08-31 |
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2019-07-02 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2012-11-13 |
| Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | DRY | Class 2 | Cardiovascular | No | 2012-11-13 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2012-12-04 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2012-11-13 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2019-07-02 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2010-06-11 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2012-11-12 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2012-11-08 |
| Suture, Nonabsorbable | GAO | Class 2 | General, Plastic Surgery | No | 2012-11-13 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2012-10-24 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2019-07-02 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2017-07-11 |
Proprietary Names
A-Oss®BONE GRAFTING MATERIAL, ANIMAL SOURCE
Bipolar Cords
Monopolar Cords
Eye Spheres / Conformers
ETIII SA Fixture System (D3.2) implant
ETIII SA Fixture System (D3.2)
DISP. STD 3/4" BLUNT NEEDLE ELECTRODE
DISP 3/4" NEEDLE ELECTRODE 24/BX
COAG SUCT TUBE DISP W/STYLT 6" 10/BX
DISP 6" EXTENDED NEEDLE ELECTRODE 24/BX
COAG SUCT TUBE DISP W/STYLT 8" 10/BX
DISP BICEPS FCPS CORD UNIV FIT 10/BX
DISP 3/4" BLADE ELECTRODE 24/BX
Suction Coagulator
TMC¿ Tri-Optic Measurement Cell
ETIV SA Dental Implants
SimpleCAP
X-TIP
Universal Plus
Acessa Handpiece (previously known as Tulip RF Probe)
PILLING
Peak PlasmaBlade Plus
DTF-13, TF-S, DTF-18, DTF-24, DTF-24b, DTF-31, 40990031, DTF-32, JSMDTF32, DTF-39, JSMDTF39, DTF-40, 4793.692, DTF-45,
Ceruleau
Peak PlsamaBlade Tonsil
A2D, A8D, B1D, B2D, C3D, CV-B1, CV-B1/S, CV-B2, CV-B2/S, CV-B3, CV-B3/S, CV-L3, CV-L3/S, CV-L5, CV-L5/S, CV-L7, CV-L7/S,
Olsen electrosurgical instruments and accessories
ELECTROSURGICAL PENCIL
Caiman
Softips
Automated Ophthalmics Softips
ET III BIO SA FIXTURE SYSTEM
Talymed Suspension
ET III Nano-HA Fixture System
ET II SA FIXTURE SYSTEM
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
HT III SA FIXTURE SYSTEM
Reusable Shielded Cable for concentric + single fiber EMG needle electrode
Reusable Shielded Cable
Reusable Unshielded Cable for detachable monopolar EMG needle electrode
Electrode Cable Thayer Electrode Cable
LW Cables and Lead Wires
Tech-Attach Connection System
CLE Cables and Lead Wires
Cabrio Connection System
Response EP Cables
MYO/Wire® Disposiable Patient Cable 2
Reuasable Unshielded Cable
Stimulation Clip
MYO/Wire® Disposable Patient Cable 2
Reusable Unshielded Cable
Neuroradium Universal Reusable Laryngeal Electrode Cable
Reusable Shielded Cable for detachable monopolar EMG needle electrode
Disposable Stimulation Clip
SteriPrep¿
BrasselerLGI¿
HG III ULTRA WIDE FIXTURE SYSTEM
HIOSSEN IMPLANT SYSTEM
Single Wire and DoubleWire Sternum Sutures
Algidex IV
Algidex Paste
impregnated gauze dressings intended for use as a primary contact layer in dressing wounds. oil emulsion, xeroform, petr
Algidex Thin Film
Algidex AG
Algidex Dermanet
Multidex Powder (various)
Multidex Powder
ET III SA ULTRA WIDE SYSTEM + (HEALING ABUTMENT)
Compress and Bandage, Camouflaged, Sterile, 4 by 4 inches (6510-00-200-3080)
Compress and Bandage, Camouflaged, Sterile, 2 by 2 inches, 4's (6510-00-200-3075)
Bandage, Gauze, Compressed, Camouflaged, Sterile, 2 inches by 6 yards (6510-00-200-3180)
Bandage, Gauze, Compressed, Camouflaged, Sterile, 3 inches by 6 yards (6510-00-200-3185)
Dressing, First Aid, Field, Camouflaged, Sterile, 11-3/4 inches square (6510-00-201-7425)
Compress and Skullcap, Camouflaged, Sterile (6510-00-201-7680)
Dressing, First Aid, Field, Camouflaged, Sterile, 7-1/2 x 8 inches (6510-00-201-7430)
Bandage, Gauze, Compressed, Camouflaged, Sterile, 4 inches by 6 yards (6510-00-200-3190)
Dressing, First Aid, Field, Camouflaged, Sterile, 4 by 6-1/4 to 7-1/4 inches (6510-00-159-4883)
Compress and Bandage, Camouflaged, Sterile, 4 by 4 inches, 4's (6510-00-200-3080)
Dressing, First Aid, Field, Camouflaged, Sterile, 4 by 6-1/4 to 7-1/4 inches inches (6510-00-159-4883)
EM Provisional
ROATING SURGICAL PUNCH
DP-40K; Pilling Aortic Punch, Standard Tip, 4
WaveOne Gold Reciprocating File Small 31mm
FlexAccess 04/20 30mm
WaveOne Gold Reciprocating File Small 25mm
WaveOne Gold Reciprocating File Primary 21mm DEMO
WaveOne Gold Reciprocating File Small 21mm DEMO
WaveOne Gold Reciprocating File Medium 21mm
WaveOne Gold Reciprocating File Primary 25mm DEMO
WaveOne Gold Reciprocating File Small 21mm
WaveOne Gold Reciprocating File Small 25mm DEMO
TruShape Orifice Modifier 16mm
TRUShape 3D Conforming File Size 25 31mm
FlexAccess 04/30 30mm
WaveOne Gold Reciprocating File Primary 25mm
WaveOne Gold Reciprocating File Large 21mm
TRUShape 3D Conforming File Size 25 25mm
FlexAccess 04/30 21mm
WaveOne Gold Reciprocating File Medium 25mm DEMO
WaveOne Gold Reciprocating File Large 25mm DEMO
WaveOne Gold Reciprocating File Medium 25mm
WaveOne Gold Reciprocating File Primary 21mm
TRUShape 3D Conforming File Size 30 31mm
TRUShape 3D Conforming File Size 30 25mm
TRUShape 3D Conforming File Size 20 21mm
FlexAccess 04/25 21mm
TRUShape 3D Conforming File Size 40 21mm
WaveOne Gold Reciprocating File Large 25mm
TRUShape 3D Conforming File Size 40 25mm
TRUShape 3D Conforming File Size 20 25mm
FlexAccess 04/15 21mm
WaveOne Gold Reciprocating File Large 31mm
WaveOne Gold Reciprocating File Medium 31mm
FlexAccess 04/20 25mm
FlexAccess 04/15 25mm
FlexAccess 04/25 25mm
FlexAccess 04/25 30mm
FlexAccess 04/15 30mm
TRUShape 3D Conforming File Size 20 31mm
WaveOne Gold Reciprocating File Primary 31mm
TRUShape 3D Conforming File Size 30 21mm
TRUShape 3D Conforming File Size 25 21mm
TRUShape 3D Conforming File Size 40 31mm
FlexAccess 04/20 21mm
FlexAccess 04/30 25mm
Waveone gold files
TruShape Files
ProTaper Next
Trunatomy
WaveOne Gold Glider
ProGlider
EK Healing Abutment
EK NH Implant
EK SA Implant
EM SA Implant System
ProTaper Gold
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)