Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Wrist immobilizer, reusable FDA UDI
- Device Name
- The ManaEZ wrist is a high quality, universal wrist brace. Patent pending single pull system makes it easier for the user to self apply the brace. Low profile, high quality lace design system Universal sizing FDA UDI
- Model / Reference
- ManaEZ Wrist Universal Left FDA UDI
- Description
- The ManaEZ wrist is a high quality, universal wrist brace. Patent pending single pull system makes it easier for the user to self apply the brace. Low profile, high quality lace design system Universal sizing FDA UDI
Identifiers
- Catalog Number
- EZW3908L FDA UDI
- Primary DI / UDI-DI
- 00850998008126 FDA UDI
- FDA Product Code
- ILH FDA UDI
- GMDN Term
- Wrist immobilizer, reusable 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: Wrist immobilizer, reusable
ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wrist immobilizer, reusable.
- Rhino — MD Orthopaedics · Class I
- Elite Orthopaedics — ELITE ORTHOPAEDICS, INC. · Class I
- Rhino — MD Orthopaedics · Class I
- CoreTech — VIVE HEALTH LLC · Class I
- Elite Orthopaedics — ELITE ORTHOPAEDICS, INC. · Class I
- WELLBRACE — PANTYMED S.A. · Class I
- Rhino — MD Orthopaedics · Class I
- Rhino — MD Orthopaedics · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI 2e7e0e60-9723-4b87-902b-91d8ca4d296c 35 fields · synced Jun 8, 2026