Duns Number:989365556
Device Description: ELITE PLUS Cup Flanged - CEMENTED LPW 28mmID 43mmOD
Catalog Number
965228043
Brand Name
ELITE PLUS
Version/Model Number
9652-28-043
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
K871867
Product Code
JDI
Product Code Name
Prosthesis, hip, semi-constrained, metal/polymer, cemented
Public Device Record Key
e44b95c2-4a93-4b24-aae7-7af6b2e929da
Public Version Date
September 09, 2020
Public Version Number
4
DI Record Publish Date
September 24, 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 | 3549 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2188 |
| 3 | A medical device with high risk that requires premarket approval | 418 |