Identity
- Trade Name
- NuStat FDA UDI
- Generic Name
- Wound dressing kit, non-medicated FDA UDI
- Model / Reference
- N-0404-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850392006582 FDA UDI
- 510(k) Number
- K160578 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound dressing kit, non-medicated FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
NuStat by Beeken Biomedical — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K160578 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beeken Biomedical
Sources (1)
- FDA UDI 5e6fb127-7022-4c8d-a8ae-291b1a73c3c3 34 fields · synced May 30, 2026