Duns Number:080277500
Device Description: Aria valve plus auto-expulsion valve for installation in lower-limb prosthesis sockets for Aria valve plus auto-expulsion valve for installation in lower-limb prosthesis sockets for suction suspension.
Catalog Number
CA200-AVP
Brand Name
Aria Valve Plus (US)
Version/Model Number
CA200-AVP
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
4bb3477b-338a-448c-8695-bcb5dfabf474
Public Version Date
August 12, 2021
Public Version Number
2
DI Record Publish Date
December 17, 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 | 88 |