FDA Registration
Active
🇺🇸 United States
Depuy (NR) - CELLECT BONE MARRO; CONFIDENCE SPINAL CEMENT SYSTEM
Reg #: 2245304
·
FEI: 2245304
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 2245304
- FEI Number
- 2245304
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9 Apollo Dr
- City
- WHIPPANY
- State
- NJ
- ZIP
- 07981
- Country
- US
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 |
|---|---|---|---|---|---|
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2012-11-07 |
Proprietary Names
Depuy (NR) - CELLECT BONE MARRO; CONFIDENCE SPINAL CEMENT SYSTEM
Merit1383 (NT,SN) - ShortStop Advantage Temporary Sharps Holder
Merit1383 (SN) - ShortStop Advantage Temporary Sharps Holder
Merit1383 (SN) - ShortStop Temporary Sharps Holder
BVI1689 (EP1, CH1) - Peribulbar
Merit1383 (TM) - BackStop Plus Closed Waste Basin
BVI1689 (CH1,EP1) - Retrobulbar
Ranfac3098 (NR) - SS-1529, Hypodermic Needle, S-115
Clearside6394 (MN,SP) - SCS Microinjector
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)