Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Elbow immobilizer FDA UDI
- Device Name
- This universal-fit range-of-motion elbow brace is a great alternative to casting or repetitive splinting. Designed to treat any injury in which a limited range of elbow motion is desired. Features: Adjustable straps to fit universally. Lightweight design for comfort and ease of use. ROM hinge features flexion settings from 0-120 degrees and extension settings from 0-90 degrees. FDA UDI
- Model / Reference
- Cabo Elbow Left FDA UDI
- Description
- This universal-fit range-of-motion elbow brace is a great alternative to casting or repetitive splinting. Designed to treat any injury in which a limited range of elbow motion is desired. Features: Adjustable straps to fit universally. Lightweight design for comfort and ease of use. ROM hinge features flexion settings from 0-120 degrees and extension settings from 0-90 degrees. FDA UDI
Identifiers
- Catalog Number
- CE001L FDA UDI
- Primary DI / UDI-DI
- 00810113680200 FDA UDI
- FDA Product Code
- IQQ FDA UDI
- GMDN Term
- Elbow immobilizer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 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: Elbow immobilizer
ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Elbow immobilizer.
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- Vive — VIVE HEALTH LLC · Class I
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- Vive — VIVE HEALTH LLC · Class I
- Elbow Immobilizer — XEMAX SURGICAL PRODUCTS, INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., 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 9e85432d-37c3-4139-8213-0330ea26081f 35 fields · synced May 30, 2026