FDA UDI
In Commercial Distribution
🇺🇸 United States
ManaMed
DI: 00810113680460
·
Model: ManaEZ Collar 80
·
Manamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ManaMed
- Primary DI
- 00810113680460
- Version / Model
- ManaEZ Collar 80
- Catalog Number
- EZC080
- Company Name
- Manamed, Inc.
- Labeler DUNS
- 084042331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-20
- Public Version
- 2
- Public Version Date
- 2024-07-11
- Public Version Status
- Update
- Public Device Record Key
- ee66a494-8318-4ff9-b582-161cd1dfc109
Device 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IQK | Orthosis, Cervical | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41039 | Cervical spine collar, reusable | A prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810113680460 | GS1 |