Duns Number:078703080
Device Description: Distal Radius Plating System Case Lid
Catalog Number
MDS14120201
Brand Name
Distal Radius Plating System Case Lid
Version/Model Number
MDS14120201
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
9d3d1efd-a922-4dd1-ab21-88010acb0a4a
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
December 17, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 464 |