Aria Valve Plus (US) - Aria valve plus auto-expulsion valve for - CYPRESS ADAPTIVE, LLC

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

ISP

Product Code Name

Valve, Prosthesis

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CYPRESS ADAPTIVE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 88