Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Cast boot FDA UDI
- Device Name
- The ManaEZ Boot Pediatric is a controlled ankle motion (CAM) walking boot for children and are to be worn to help stabilize the foot and ankle after an injury or surgery. ManaEZ Boot Pediatric boots are color coded for an easy size selection. Small: Pink Medium: Yellow Large: Teal Features and Benefits: Rocker bottom to stimulate natural gait Low profile; lightweight Anatomically-shaped plastic uprights to help facilitate a secure fit for children Easy to apply and adjust with a simple strapping and liner system Fits right and left Ideal for: Treatment of stable fractures and ankle sprains, early rehabilitation of a variety of post-surgical and post-trauma indications requiring fixed control FDA UDI
- Model / Reference
- ManaEZ Boot Pediatric - Medium FDA UDI
- Description
- The ManaEZ Boot Pediatric is a controlled ankle motion (CAM) walking boot for children and are to be worn to help stabilize the foot and ankle after an injury or surgery. ManaEZ Boot Pediatric boots are color coded for an easy size selection. Small: Pink Medium: Yellow Large: Teal Features and Benefits: Rocker bottom to stimulate natural gait Low profile; lightweight Anatomically-shaped plastic uprights to help facilitate a secure fit for children Easy to apply and adjust with a simple strapping and liner system Fits right and left Ideal for: Treatment of stable fractures and ankle sprains, early rehabilitation of a variety of post-surgical and post-trauma indications requiring fixed control FDA UDI
Identifiers
- Catalog Number
- EZBPEDM FDA UDI
- Primary DI / UDI-DI
- 00810113680439 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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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 ae8d0bc2-c7b8-4546-8799-f9b611450ab8 35 fields · synced May 30, 2026