Duns Number:968990812
Device Description: KEELED GLENOID TRIAL
Catalog Number
MWH727
Brand Name
Tornier Perform
Version/Model Number
MWH727
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
Orthopedic manual surgical instrument
Public Device Record Key
d5f311cc-3a3b-41b1-9c86-76f43ed023ca
Public Version Date
August 18, 2022
Public Version Number
1
DI Record Publish Date
August 10, 2022
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 | 1670 |
2 | A medical device with a moderate to high risk that requires special controls. | 3042 |