Identity
- Trade Name
- PLASTIC HEEL CUP RED 6/BX LG FDA UDI
- Generic Name
- Cast walking heel FDA UDI
- Model / Reference
- 08140449 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00610570002573 FDA UDI
- FDA Product Code
- KNP FDA UDI
- GMDN Term
- Cast walking heel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
No
FDA UDI
Category: Cast walking heel
Plastic Heel Cup Red 6/Bx Lg by Bird & Cronin, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cast walking heel.
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- TULI'S HEEL CUP LG — BIRD & CRONIN, LLC · Class I
- LEVEL-RITE HEEL LIFT SM — BIRD & CRONIN, LLC · Class I
- TULI'S PRO HEEL CUP LG — BIRD & CRONIN, LLC · Class I
- TULI'S PRO HEEL CUP SM — BIRD & CRONIN, LLC · Class I
- TULI'S HEEL CUP REG — BIRD & CRONIN, 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 |
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Manufacturer
- Manufacturer
- Bird & Cronin, Llc
Sources (1)
- FDA UDI 2a299059-9ae9-4c3c-8978-8f102bf7b300 32 fields · synced May 30, 2026