Identity
- Trade Name
- TCC-EZ® FDA UDI
- Generic Name
- Cast boot FDA UDI
- Device Name
- TOTAL CONTACT CAST SYSTEM - 10 Casting Systems, 2 Extra Large Boots FDA UDI
- Model / Reference
- TCC24224 FDA UDI
- Description
- TOTAL CONTACT CAST SYSTEM - 10 Casting Systems, 2 Extra Large Boots FDA UDI
Identifiers
- Catalog Number
- TCC2-4224 FDA UDI
- Primary DI / UDI-DI
- 00809958007211 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
- Not 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
Tcc-Ez® by Acell, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Acell, Inc.
Sources (1)
- FDA UDI 8d402bf2-10bc-4d43-b984-80647b0b89a0 38 fields · synced Jun 8, 2026