AccessGUDID - DEVICE: ATLAS Review for i. Profiler plus (04250668606632)

GUDID

Device Identifier (DI) Information

Brand Name: ATLAS Review for i. Profiler plus
Version or Model: 000000-2360-422
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000000-2360-422
Company Name: Carl Zeiss Vision GmbH

Primary DI Number: 04250668606632
Issuing Agency: GS1
Commercial Distribution End Date:
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?
45735	Corneal topography system application software	An individual software application program or group of programs, routines or algorithms intended to add specific computer assisted display, processing and/or analysis capabilities to a corneal topography system or system analyser. A basic set of applications programs and routines are included with such systems and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	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: 4617a423-0f70-4e88-bae1-5c69bc40abc7
Public Version Date: January 11, 2021
Public Version Number: 1
DI Record Publish Date: January 01, 2021