Aria Universal Mini Valve Key - Tool to install or remove valves for prosthesis - CYPRESS ADAPTIVE, LLC

Duns Number:080277500

Device Description: Tool to install or remove valves for prosthesis sockets

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More Product Details

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

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

e0ac7eed-3d55-4510-84ee-7f172d87b2dc

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

October 01, 2022

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