Duns Number:877234002
Device Description: FlexiOH Short Arm Immobilizer is indicated for Distal radius stable fracture , wrist fract FlexiOH Short Arm Immobilizer is indicated for Distal radius stable fracture , wrist fracture and wrist sprain.
Catalog Number
-
Brand Name
FlexiOH
Version/Model Number
Short Arm Immobilizer XXS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
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
6dec5c9e-4816-4e2a-92a9-4debe61390d7
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 29, 2020
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 | 1 |