Duns Number:960754430
Device Description: M4S OA VALGUS GRAPHITE RIGHT XXL
Catalog Number
-
Brand Name
MEDI
Version/Model Number
62706
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
Yes
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
ac9ba114-f9d6-404a-a42e-33840f6acb78
Public Version Date
August 30, 2022
Public Version Number
5
DI Record Publish Date
December 19, 2018
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 | 2971 |
2 | A medical device with a moderate to high risk that requires special controls. | 9550 |