AccessGUDID - DEVICE: AdaptDx Pro USB-C Headset Cable (00850006785070)

GUDID

Device Identifier (DI) Information

Brand Name: AdaptDx Pro USB-C Headset Cable
Version or Model: 10388
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MACULOGIX, INC.

Primary DI Number: 00850006785070
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962692179 *Terms of Use

Device Description: This is a USB-C cable used to connect the AdaptDx Pro handheld controller with the AdaptDx Pro headset.

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?
10024	Adaptometer	A mains electricity (AC-powered) ophthalmic device that provides a stimulating light source having various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUM	Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation

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: 1da3ca31-e67d-48ba-8cb1-cfb2b5c32483
Public Version Date: February 04, 2022
Public Version Number: 1
DI Record Publish Date: January 27, 2022