Identity
- Trade Name
- Unite Medical® FDA UDI
- Generic Name
- Cast boot FDA UDI
- Device Name
- Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility. FDA UDI
- Model / Reference
- Short Walking Boot - Pneumatic (Medium) FDA UDI
- Description
- Introducing the Unite Medical® Short Pneumatic Walking Boot, designed for superior support and comfort in treating soft tissue injuries, grade 2 and 3 sprains, stable fractures, and post-operative stabilization. This boot features an inflatable bladder for enhanced immobilization, a lightweight low rocker profile for greater comfort, and a cushioned heel for optimal energy absorption. Its versatile design fits either foot and promotes a natural gait pattern for improved mobility. FDA UDI
Identifiers
- Catalog Number
- PWB6061-M-S FDA UDI
- Primary DI / UDI-DI
- 00850063323024 FDA UDI
- FDA Product Code
- ITW FDA UDI
- GMDN Term
- Cast boot 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Unite Medical® by Unite Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Unite Medical, Llc
Sources (1)
- FDA UDI e24e0364-506d-4b9a-855f-8bdd645cd7e2 35 fields · synced Jun 8, 2026