Identity
- Trade Name
- AV-Seal® FDA UDI
- Generic Name
- Non-organic haemostatic agent FDA UDI
- Device Name
- AV-Seal® Disc FDA UDI
- Model / Reference
- DIAL001 FDA UDI
- Description
- AV-Seal® Disc FDA UDI
Identifiers
- Catalog Number
- DIAL001 FDA UDI
- Primary DI / UDI-DI
- 00834061000231 FDA UDI
- 510(k) Number
- K130324 FDA UDI
- FDA Product Code
- QSY FDA UDI
- GMDN Term
- Non-organic haemostatic agent 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
Yes
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
Dimensions & Sizes
- Size
- Length — 2.4 Centimeter FDA UDIWidth — 1.2 Centimeter FDA UDI
AV-Seal® by Biolife, L.l.c. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K130324 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
- Biolife, L.l.c.
Sources (1)
- FDA UDI e1e20f72-3b08-4657-9042-3e0a8ae4d5f5 39 fields · synced May 29, 2026