Duns Number:084042331
Device Description: The brace is intended exclusively for orthotic fittings of the cervical spine and exclusiv 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 performanceTwo-piece design for easy fitting and adjustingMade with vented and breathable linter9 different adjustment settings
Catalog Number
EZC074
Brand Name
ManaMed
Version/Model Number
ManaEZ Collar 74
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IQK
Product Code Name
Orthosis, Cervical
Public Device Record Key
4db6d3c5-f9d9-4292-8381-8a1b24545db6
Public Version Date
June 28, 2022
Public Version Number
1
DI Record Publish Date
June 20, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 128 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |