AccessGUDID - DEVICE: VISUFIT 1000 (04250668606687)

GUDID

Device Identifier (DI) Information

Brand Name: VISUFIT 1000
Version or Model: 000000-2351-293
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000000-2351-293
Company Name: Carl Zeiss Vision GmbH

Primary DI Number: 04250668606687
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?
65137	Vision corrective spectacles centration image analysis software	An application software program intended to be used to analyse images of a patient wearing spectacle frames to measure centration data (e.g., pupil position relative to frame, angle of frame relative to face) used to manufacture customized corrective spectacles.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMM	Distometer

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: 809b1412-8cad-474c-a22b-901d5feb3ed4
Public Version Date: December 08, 2022
Public Version Number: 3
DI Record Publish Date: January 01, 2021