AccessGUDID - DEVICE: M&S Technologies ACUITYex (00850040295238)

GUDID

Device Identifier (DI) Information

Brand Name: M&S Technologies ACUITYex
Version or Model: EX-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: The Hilsinger Company Parent LLC

Primary DI Number: 00850040295238
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118021111 *Terms of Use

Device Description: M&S Technologies ACUITYex

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):	Yes
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?
35922	Visual acuity projector	A mains electricity (AC-powered) ophthalmic device intended to project an image on a screen to test visual acuity. The images typically include block letters (Snellen chart) and/or other symbols (e.g., recognizable objects used for children who cannot read) viewed in gradually decreasing size. They are typically identified according to the distance at which they are ordinarily visible (normally 6 metres or 20 feet).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QTO	Digital Visual Acuity Test

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: 52371e9d-42d0-46f7-a5b4-a08061f3e656
Public Version Date: December 21, 2023
Public Version Number: 2
DI Record Publish Date: July 06, 2022