Duns Number:968990812
Catalog Number
DWJ514
Brand Name
Tornier Perform® Reversed Augmented Glenoid
Version/Model Number
DWJ514
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
Yes
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
K161742,K161742
Product Code
KWS
Product Code Name
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Public Device Record Key
51d372e9-90b8-41fc-9e76-9ce39168e2ef
Public Version Date
May 18, 2022
Public Version Number
1
DI Record Publish Date
May 10, 2022
Package DI Number
10846832062031
Quantity per Package
1
Contains DI Package
00846832092130
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1670 |
2 | A medical device with a moderate to high risk that requires special controls. | 3042 |