Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Cast boot FDA UDI
- Device Name
- The ManaEZ Boot Air is a tall pneumatic walker boot built with a unique rocker bottom to simulate natural gait. Rocker bottom to stimulate natural gait Pneumatic pump - tall design Large air bladder creates a larger surface for contact pressure to control swelling and ensure snug fit FDA UDI
- Model / Reference
- ManaEZ Boot Air XXL FDA UDI
- Description
- The ManaEZ Boot Air is a tall pneumatic walker boot built with a unique rocker bottom to simulate natural gait. Rocker bottom to stimulate natural gait Pneumatic pump - tall design Large air bladder creates a larger surface for contact pressure to control swelling and ensure snug fit FDA UDI
Identifiers
- Catalog Number
- EZBA01XXL FDA UDI
- Primary DI / UDI-DI
- 00810113680415 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
ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- TCC-EZ® — ACELL, INC. · 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
- Manamed Llc
Sources (1)
- FDA UDI d88ce004-ad99-43c5-961a-b25d2a154e63 35 fields · synced May 30, 2026