Identity
- Trade Name
- TCC-EZ® FDA UDI
- Generic Name
- Cast boot FDA UDI
- Device Name
- TCC-EZ® TOTAL CONTACT CAST SYSTEM - 10 Casting Systems FDA UDI
- Model / Reference
- TCC23001 FDA UDI
- Description
- TCC-EZ® TOTAL CONTACT CAST SYSTEM - 10 Casting Systems FDA UDI
Identifiers
- Catalog Number
- TCC2-3001 FDA UDI
- Primary DI / UDI-DI
- 00809958005217 FDA UDI
- FDA Product Code
- ITG FDA UDI
- GMDN Term
- Cast boot FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
No
FDA UDI
Category: Cast boot
Tcc-Ez® by Acell, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cast boot.
- Health Design Low Profile Cast Boot — DARCO International, Inc. · Class I
- Health Design Low Profile Cast Boot — DARCO International, Inc. · Class I
- ManaMed — MANAMED LLC · Class I
- Health Design Polycast Cast Boot — DARCO International, Inc. · Class I
- Health Design Vinyl Cast Boot — DARCO International, Inc. · Class I
- ManaMed — MANAMED LLC · Class I
- ManaMed — MANAMED LLC · Class I
- ManaMed — MANAMED LLC · 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
- Acell, Inc.
Sources (1)
- FDA UDI a73d516e-d1e5-4c55-9116-3f9098d4e6a8 37 fields · synced May 30, 2026