FDA Registration
Active
🇺🇸 United States
NUSTAT Flex
Reg #: 3001186500
·
FEI: 3001186500
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Ovik Health (a division of Miliken & Co)
- Registration Number
- 3001186500
- FEI Number
- 3001186500
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 920 Milliken Rd
- City
- SPARTANBURG
- State
- SC
- ZIP
- 29303
- Country
- US
Regulatory Submissions
- 510(k) Number
- K072890
Owner / Operator
- Firm Name
- OVIK Health
- Operator Number
- 9073743
- Address
- 920 MILLIKEN ROAD
- City
- Spartanburg
- State
- SC
- Postal Code
- 29303
- Country
- US
- Correspondent
- Sherry L Albritton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2014-12-15 |
Proprietary Names
NUSTAT Flex
NUSTAT PAK
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device