Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- This universally sized support brace can be worn on either the left or right foot. It is intended for use after injury and throughout the recovery period. Universally sized Low profile for minimal bulk in shoe Adjustable straps allow left or right usage FDA UDI
- Model / Reference
- ManaEZ Ankle Stirrup Universal FDA UDI
- Description
- This universally sized support brace can be worn on either the left or right foot. It is intended for use after injury and throughout the recovery period. Universally sized Low profile for minimal bulk in shoe Adjustable straps allow left or right usage FDA UDI
Identifiers
- Catalog Number
- EZAS4350 FDA UDI
- Primary DI / UDI-DI
- 00810113680408 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
ManaMed by Manamed 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
- Manamed Llc
Sources (1)
- FDA UDI f2a77964-e0d6-41bd-bea1-5dec6264bfa4 35 fields · synced May 30, 2026