Duns Number:079118736
Device Description: DURAMER®DOME/FIN SHELL LINER 60mm OD 28mm ID
Catalog Number
3821286000
Brand Name
DURAMER®
Version/Model Number
3821285600
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
MEH
Product Code Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Public Device Record Key
58a11c8b-cdda-49b9-ab7e-f6cef3c83b76
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 22, 2015
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 | 7823 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12222 |
| 3 | A medical device with high risk that requires premarket approval | 109 |