Duns Number:084042331
Device Description: ManaEZ Soft Collar Universal provides uniform support, comfort, and support of the cervica ManaEZ Soft Collar Universal provides uniform support, comfort, and support of the cervical spine.Universally sizedMedium density foam
Catalog Number
EZ120
Brand Name
ManaMed
Version/Model Number
ManaEZ Soft Collar Uni
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
ff0c3e66-c080-4715-925b-6d38cd858fd5
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 |