AccessGUDID - DEVICE: Colors in Optics (00781268850841)

GUDID

Device Identifier (DI) Information

Brand Name: Colors in Optics
Version or Model: COLORS CX128 - TEA (+1.75)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CX128 - TEA (+1.75)
Company Name: Colors In Optics, Ltd.

Primary DI Number: 00781268850841
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060215290 *Terms of Use

Device Description: Readers

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):	Yes
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: 37574a99-1ab9-4ffd-8de7-ad902b35df85
Public Version Date: November 03, 2022
Public Version Number: 1
DI Record Publish Date: October 26, 2022