FDA Registration
Active
🇺🇸 United States
OVIK Health
Reg #: 3001186500
·
FEI: 3001186500
·
Expires 2026
Products
6
Proprietary Names
21
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- OVIK Health
- Registration Number
- 3001186500
- FEI Number
- 3001186500
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 920 Milliken Rd
- City
- SPARTANBURG
- State
- SC
- ZIP
- 29303
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093188
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 |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2012-01-27 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2012-11-16 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2009-06-18 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2010-11-17 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2019-03-26 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2008-06-26 |
Proprietary Names
Ultra Silver
AFM Ultra Ag
ComfortDry
InterDry
ASSIST Silver
AFM Ag Assist
Ultra
ULTRA Border
ASSIST Absorbent Pad
Tritec
AGILE
NuStat XR
PermeaDerm
Sterile Absorptive Pad with AFM
AFM Absorbent Pad
NUSTAT Flex
NUSTAT PAK
Tritec Silver
SELECTSILVER
SELECTCARE
AFM Ag
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device