Identity
- Trade Name
- Bioseal Inc. FDA UDI
- Generic Name
- Cast stockinette FDA UDI
- Device Name
- Cast Padding Sof-Rol FDA UDI
- Model / Reference
- 3164RG/24 FDA UDI
- Description
- Cast Padding Sof-Rol FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630094164946 FDA UDI
- FDA Product Code
- FRL FDA UDI
- GMDN Term
- Cast stockinette FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5300 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: Cast stockinette
Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cast stockinette.
- Tex-Care Medical — Flynt/Amtex, Inc. · Class I
- BICRO FELT CAST PADDING 1/4X21X36" — BIRD & CRONIN, LLC · Class I
- Tex-Care Medical — Flynt/Amtex, Inc. · Class I
- Webril — Cardinalhealth · Class I
- 5403 Bandages and Supplies — SIGVARIS, INC. · Class I
- 5438 Bandages and Supplies — SIGVARIS, INC. · Class I
- 5054 Bandages and Supplies — SIGVARIS, INC. · Class I
- Curity — Cardinalhealth · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioseal
Sources (1)
- FDA UDI fd192273-7f0b-4805-b29a-a1b9dd75debe 33 fields · synced Jun 8, 2026