Duns Number:079118736
Device Description: CONSERVE® A-CLASS® BFH® HEAD MEDIUM NECK 54MM
Catalog Number
38AM5400
Brand Name
CONSERVE®
Version/Model Number
38AM5400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
JDL
Product Code Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Public Device Record Key
7c58fcf4-47be-4b7a-b3d7-2f82ddba4907
Public Version Date
April 06, 2020
Public Version Number
3
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 |