Duns Number:080277500
Device Description: Tool to install or remove valves for prosthesis sockets
Catalog Number
-
Brand Name
Aria Universal Mini Valve Key
Version/Model Number
CA100-MVK
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
e0ac7eed-3d55-4510-84ee-7f172d87b2dc
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
October 01, 2022
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 |