FDA Registration
Active
🇺🇸 United States
DVL-Op6436 (TM) - BRCD-05 Breast Reduction Compression Device
Reg #: 1424263
·
FEI: 3003015552
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 1424263
- FEI Number
- 3003015552
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2500 Commerce Dr
- City
- Libertyville
- State
- IL
- ZIP
- 60048
- 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 |
|---|---|---|---|---|---|
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2012-11-07 |
Proprietary Names
DVL-Op6436 (TM) - BRCD-05 Breast Reduction Compression Device
DVL-Op6436 (TM) - BRCDXL-05 Breast Reduction Compression Device XL
Merit1383 (TM) - Finale Radial Compression System
Merit1383 (TM) - Finale Readial Arter Compression Device
PrecisionMedical (NR) - T-RING
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)