Duns Number:084042331
Device Description: This brace is intended for use after an upper arm fracture. It stabilizes the area while a This brace is intended for use after an upper arm fracture. It stabilizes the area while allowing motion in the hand and forearm.Lightweight and breathable designAdjustable straps fit any sizeCan be worn on both right and left arms
Catalog Number
EZH3980
Brand Name
ManaMed
Version/Model Number
ManaEZ Humerus Universal
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
IQI
Product Code Name
Orthosis, Limb Brace
Public Device Record Key
1e18e6cd-182c-4952-9f6a-4bd159521163
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 |