Identity
- Trade Name
- Unite Medical® FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic ankle sprains, hind foot arthritis, ankle tendonitis, and ankle arthritis. The ankle foot orthosis is a lightweight, low profile brace, great for extended wear. FDA UDI
- Model / Reference
- Ankle Foot Orthosis (Right,Medium) FDA UDI
- Description
- The Unite Medical® ankle foot orthosis is indicated for ankle instabilities, acute & chronic ankle sprains, hind foot arthritis, ankle tendonitis, and ankle arthritis. The ankle foot orthosis is a lightweight, low profile brace, great for extended wear. FDA UDI
Identifiers
- Catalog Number
- AFO0671R-M FDA UDI
- Primary DI / UDI-DI
- 00850012035497 FDA UDI
- FDA Product Code
- ITW FDA UDI
- GMDN Term
- Ankle/foot orthosis 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: Ankle/foot orthosis
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 c167c717-4f88-4feb-8bf5-79ad30adf3c1 35 fields · synced May 31, 2026