Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Cervical spine collar, reusable FDA UDI
- Device Name
- The brace is intended exclusively for orthotic fittings of the cervical spine and exclusively for contact with intact skin. The brace must be used in accordance with indications determined by a physician. Designed for comfort and performance Two-piece design for easy fitting and adjusting Made with vented and breathable linter 9 different adjustment settings FDA UDI
- Model / Reference
- ManaEZ Collar 80 FDA UDI
- Description
- The brace is intended exclusively for orthotic fittings of the cervical spine and exclusively for contact with intact skin. The brace must be used in accordance with indications determined by a physician. Designed for comfort and performance Two-piece design for easy fitting and adjusting Made with vented and breathable linter 9 different adjustment settings FDA UDI
Identifiers
- Catalog Number
- EZC080 FDA UDI
- Primary DI / UDI-DI
- 00810113680460 FDA UDI
- FDA Product Code
- IQK FDA UDI
- GMDN Term
- Cervical spine collar, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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: Cervical spine collar, reusable
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 ee66a494-8318-4ff9-b582-161cd1dfc109 34 fields · synced May 31, 2026