FDA Registration
Active
🇺🇸 United States
Merit1383 (NT,SN) - StayFIX Fixation Device
Reg #: 1047843
·
FEI: 1047843
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1047843
- FEI Number
- 1047843
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2072 SOUTHPORT RD., HWY. 295
- City
- SPARTANBURG
- State
- SC
- ZIP
- 29306
- 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 |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-11-16 |
Proprietary Names
Merit1383 (NT,SN) - StayFIX Fixation Device
PFMMedical6614 (TM) - ASEPT Drainage Catheter Dressing Kit (Ref M7041)
Insulet5490 (NR) - PodPals Adhesive Overlay
Ursel11054 (MN) - TRU-FIX Catheter Fixation Kit
Insulet5490 (NR) - Adhesive Overlay
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)