Duns Number:317931954
Device Description: Transtibial Exhaust Valve active.valve, to secure the prosthesis within the socket by vacu Transtibial Exhaust Valve active.valve, to secure the prosthesis within the socket by vacuum, Aluminium
Catalog Number
6P50
Brand Name
Transtibial Exhaust Valve active.valve
Version/Model Number
6P50
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISP
Product Code Name
Valve, Prosthesis
Public Device Record Key
e0380f7a-187e-485d-a2da-3d012d9c92e2
Public Version Date
November 12, 2020
Public Version Number
1
DI Record Publish Date
November 04, 2020
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 | 64 |