FDA Registration
Active
🇺🇸 United States
Bandage, Gauze, Compressed, Camouflaged, Sterile, 2 inches by 6 yards (6510-00-200-3180)
Reg #: 2245590
·
FEI: 2245590
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 2245590
- FEI Number
- 2245590
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 75 Tilbury Rd
- City
- Salem
- State
- NJ
- ZIP
- 08079
- Country
- US
Regulatory Submissions
- 510(k) Number
- K891133
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 |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2012-11-13 |
Proprietary Names
Bandage, Gauze, Compressed, Camouflaged, Sterile, 2 inches by 6 yards (6510-00-200-3180)
Compress and Bandage, Camouflaged, Sterile, 2 by 2 inches, 4's (6510-00-200-3075)
Compress and Bandage, Camouflaged, Sterile, 4 by 4 inches (6510-00-200-3080)
Compress and Skullcap, Camouflaged, Sterile (6510-00-201-7680)
Dressing, First Aid, Field, Camouflaged, Sterile, 11-3/4 inches square (6510-00-201-7425)
Dressing, First Aid, Field, Camouflaged, Sterile, 7-1/2 x 8 inches (6510-00-201-7430)
Bandage, Gauze, Compressed, Camouflaged, Sterile, 3 inches by 6 yards (6510-00-200-3185)
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)
Dressing, First Aid, Field, Camouflaged, Sterile, 4 by 6-1/4 to 7-1/4 inches inches (6510-00-159-4883)
Compress and Bandage, Camouflaged, Sterile, 4 by 4 inches, 4's (6510-00-200-3080)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)