Duns Number:261839898
Catalog Number
-
Brand Name
trial glenoid base size 50
Version/Model Number
261091
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K093599
Product Code
HSD
Product Code Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Public Device Record Key
cd7aed91-8e0d-4687-986c-c5be365c177e
Public Version Date
March 21, 2019
Public Version Number
1
DI Record Publish Date
March 13, 2019
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 1182 |