Duns Number:084042331
Device Description: ManaEZ Ice Wrap Back is a quick fitting, universal, back orthosis. This back brace also in ManaEZ Ice Wrap Back is a quick fitting, universal, back orthosis. This back brace also includes an ice pack.Removable ice packLightweight, latex free breathable materialEffortless application, universal size with hook and loop closure
Catalog Number
EZIWBACK01
Brand Name
ManaMed Inc
Version/Model Number
ManaEZ Ice Wrap Back
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"
Yes
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
IQE
Product Code Name
Orthosis, Lumbar
Public Device Record Key
505feb43-d5c7-4afb-87a7-772fe82f5c2e
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 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 |