AccessGUDID - DEVICE: Vista Ankle (00850013242283)

GUDID

Device Identifier (DI) Information

Brand Name: Vista Ankle
Version or Model: CA500-BMP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CA500-BMP
Company Name: CYPRESS ADAPTIVE, LLC

Primary DI Number: 00850013242283
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080277500 *Terms of Use

Device Description: a universal single axis prosthetic ankle for elevated vacuum suspension

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?
41537	Ankle-disarticulation prosthesis	An artificial substitute for part of the lower limb after amputation at the ankle joint used to restore some of the appearance and/or function of the normal anatomy.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ISY	Joint, Knee, External Limb Component

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: 76548607-3b66-4e21-a0dc-775e28f8d675
Public Version Date: December 10, 2019
Public Version Number: 1
DI Record Publish Date: December 02, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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