AccessGUDID - DEVICE: M BY MAX STUDIO (00802807354061)

GUDID

Device Identifier (DI) Information

Brand Name: M BY MAX STUDIO
Version or Model: 4134-MSR3MEN BRIGHT GEO
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Evolutioneyes, Inc.

Primary DI Number: 00802807354061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 825224459 *Terms of Use

Device Description: READER 3 PACK

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?
42832	Magnifying spectacles	A device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOI	Spectacle, magnifying

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: 941cc842-fc8d-4eea-818e-f0dcbdbf8382
Public Version Date: December 14, 2022
Public Version Number: 1
DI Record Publish Date: December 06, 2022