FDA Registration
Active
🇺🇸 United States
SmithMed3794 (NR) - Jelco Hypodermic Needle-Pro Device for Insulin Injections
Reg #: 1220477
·
FEI: 1220477
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1220477
- FEI Number
- 1220477
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 435 WHITNEY ST.
- City
- Northboro
- State
- MA
- ZIP
- 01532
- Country
- US
Regulatory Submissions
- 510(k) Number
- K014073
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 |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-01-08 |
Proprietary Names
SmithMed3794 (NR) - Jelco Hypodermic Needle-Pro Device for Insulin Injections
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)