Duns Number:129278169
Catalog Number
162646
Brand Name
Distal Centralizer/Centering Sleeve
Version/Model Number
162646
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
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
K193546,K942479
Product Code
JDG
Product Code Name
Prosthesis, hip, femoral component, cemented, metal
Public Device Record Key
4adf95ac-09ac-4ceb-ad68-2d273a1558a5
Public Version Date
May 02, 2022
Public Version Number
1
DI Record Publish Date
April 23, 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 | 11962 |
2 | A medical device with a moderate to high risk that requires special controls. | 28376 |
3 | A medical device with high risk that requires premarket approval | 36 |
U | Unclassified | 4 |