Duns Number:006426316
Device Description: AIRCAST ANKLE BRACE - RIGHT, WHITE
Catalog Number
4566
Brand Name
Mueller Aircast Ankle Brace Right White
Version/Model Number
4566
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
FZF
Product Code Name
SPLINT, EXTREMITY, INFLATABLE, EXTERNAL
Public Device Record Key
8edc2573-cb39-4c20-b3f1-1cd8c2064bbb
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 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 | 148 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |