FDA Registration
Active
🇺🇸 United States
Nurse11268 (GR) - USP Normal Saline, 500mL, Screw Top Bottle
Reg #: 1643817
·
FEI: 1643817
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC
- Registration Number
- 1643817
- FEI Number
- 1643817
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1435 ISOMEDIX PLACE
- City
- EL PASO
- State
- TX
- ZIP
- 79936
- Country
- US
Regulatory Submissions
- 510(k) Number
- K083042
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2022-01-05 |
Proprietary Names
Nurse11268 (GR) - USP Normal Saline, 500mL, Screw Top Bottle
Nurse11268 (GR) - USP Sterile Water, 500mL, Screw Top Bottle
Nurse11268 (GR) - USP Normal Saline, 250mL Screw Top Bottle
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)