Identity
- Trade Name
- Bioseal Inc. FDA UDI
- Generic Name
- Gauze strip, non-antimicrobial FDA UDI
- Device Name
- Burn Net Size 5 FDA UDI
- Model / Reference
- 4462/20 FDA UDI
- Description
- Burn Net Size 5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630094044620 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- Gauze strip, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gauze strip, non-antimicrobial
Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Bioseal
Sources (1)
- FDA UDI b9f758c9-e1b6-4db7-9b61-e8824a57c478 33 fields · synced Jun 8, 2026