Duns Number:078703080
Device Description: Elbow Plating System Screw Caddy
Catalog Number
MDS171206
Brand Name
Elbow Plating System Screw Caddy
Version/Model Number
MDS171206
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
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
73d8fe66-44bb-441d-8ae7-e7ab2a269095
Public Version Date
November 17, 2021
Public Version Number
1
DI Record Publish Date
November 09, 2021
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 |