AccessGUDID - DEVICE: Avatar Generation (04250668606670)

GUDID

Device Identifier (DI) Information

Brand Name: Avatar Generation
Version or Model: 000000-2351-295
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 000000-2351-295
Company Name: Carl Zeiss Vision GmbH

Primary DI Number: 04250668606670
Issuing Agency: GS1
Commercial Distribution End Date: May 25, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 333928146 *Terms of Use

Device Description: N/A

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?
38683	Camera application software	A data program designed for use in, or together with, a camera (e.g., a digital camera or video recorder) so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical device data system

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: 2292592e-5ea7-4d87-8b7f-01eb4bd93b8a
Public Version Date: July 05, 2021
Public Version Number: 2
DI Record Publish Date: January 01, 2021