Duns Number:109903521
Device Description: JOURNEY UNI ALL POLY TIBIA SIZE 6RIGHT MEDIAL/LEFT LATE JOURNEY UNI ALL POLY TIBIA SIZE 6RIGHT MEDIAL/LEFT LATERAL 9MM
Catalog Number
71422336
Brand Name
JOURNEY
Version/Model Number
71422336
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
K061779
Product Code
HSX
Product Code Name
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Public Device Record Key
fc2961e4-5e24-4416-9495-b090c014dbd1
Public Version Date
November 03, 2020
Public Version Number
4
DI Record Publish Date
August 30, 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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |