Identity
- Trade Name
- Health Design Polycast Cast Boot FDA UDI
- Generic Name
- Cast boot FDA UDI
- Device Name
- Medium Black FDA UDI
- Model / Reference
- HD-CB-PC4 FDA UDI
- Description
- Medium Black FDA UDI
Identifiers
- Catalog Number
- HD-CB-PC4 FDA UDI
- Primary DI / UDI-DI
- 00609271000438 FDA UDI
- FDA Product Code
- IPG 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
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 boot
Health Design Polycast Cast Boot by DARCO International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cast boot.
- ManaMed — MANAMED LLC · Class I
- TCC-EZ® — ACELL, INC. · Class I
- TCC-EZ® — ACELL, INC. · Class I
- ManaMed — MANAMED LLC · Class I
- TCC-EZ® — ACELL, INC. · Class I
- ManaMed — MANAMED LLC · Class I
- TCC-EZ® — ACELL, INC. · 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
- DARCO International, Inc.
Sources (1)
- FDA UDI 52cc4695-3b91-4917-9386-2185ef434723 34 fields · synced Jun 9, 2026