Duns Number:079118736
Catalog Number
EFSAN1PR
Brand Name
EVOLUTION
Version/Model Number
EFSAN1PR
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
JWH
Product Code Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Public Device Record Key
eceebe80-1643-4125-9657-30ce48f0cfbf
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
May 31, 2019
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 |