Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- This brace is intended for use after an upper arm fracture. It stabilizes the area while allowing motion in the hand and forearm. Lightweight and breathable design Adjustable straps fit any size Can be worn on both right and left arms FDA UDI
- Model / Reference
- ManaEZ Humerus Universal FDA UDI
- Description
- This brace is intended for use after an upper arm fracture. It stabilizes the area while allowing motion in the hand and forearm. Lightweight and breathable design Adjustable straps fit any size Can be worn on both right and left arms FDA UDI
Identifiers
- Catalog Number
- EZH3980 FDA UDI
- Primary DI / UDI-DI
- 00810113680491 FDA UDI
- FDA Product Code
- IQI FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use 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
Yes
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: External orthopaedic fixation system, single-use
ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use.
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- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- TrueLok — Orthofix, Inc. · Class II
- ARBOR — GLOBUS MEDICAL, INC. · Class II
- DRACO — HNM TOTAL RECON LLC · Class II
- PREFIX FIXATOR — Orthofix, Inc. · Class II
- RINGFIX — Stryker Corp. · Class II
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 1e18e6cd-182c-4952-9f6a-4bd159521163 35 fields · synced May 30, 2026