Duns Number:780455338
Device Description: Distal Radio-Ulnar Joint Stem, Standard, 4.5 mm Diameter. THIS ITEM IS NO LONGER IN DISTRI Distal Radio-Ulnar Joint Stem, Standard, 4.5 mm Diameter. THIS ITEM IS NO LONGER IN DISTRIBUTION.
Catalog Number
DRUJ-IS045
Brand Name
NA
Version/Model Number
DRUJ-IS045
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 27, 2021
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KXE
Product Code Name
Prosthesis, Wrist, Hemi-, Ulnar
Public Device Record Key
700dda7b-3b1d-4109-8387-087bb6a196d9
Public Version Date
September 06, 2021
Public Version Number
1
DI Record Publish Date
August 27, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |