AccessGUDID - DEVICE: Aria Mini Valve (00850013242016)

GUDID

Device Identifier (DI) Information

Brand Name: Aria Mini Valve
Version or Model: CA100-MV
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CA100-MV
Company Name: CYPRESS ADAPTIVE, LLC

Primary DI Number: 00850013242016
Issuing Agency: GS1
Commercial Distribution End Date: August 11, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 080277500 *Terms of Use

Device Description: Valve for installation into limb prosthesis with a small diameter and low profile.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64715	External lower-limb prosthesis suspensory component, non-powered	A non-powered device intended to be integrated in the socket shell of an external lower limb prosthesis to reduce the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It may be designed in various forms (e.g., strap, sleeve, cuff, thigh corset, shell, belt, pin, lock, valves).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISP	Valve, Prosthesis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba26b2ce-f837-4fbe-a116-aa9e5fb861c2
Public Version Date: November 25, 2021
Public Version Number: 2
DI Record Publish Date: August 11, 2021