AccessGUDID - DEVICE: Advancing Eyecare (00860014277511)

GUDID

Device Identifier (DI) Information

Brand Name: Advancing Eyecare
Version or Model: PD-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lombart Brothers, Inc.

Primary DI Number: 00860014277511
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 097420376 *Terms of Use

Device Description: AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.

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?
12805	Ophthalmodiastimeter	An ophthalmic instrument for determining the proper distance at which to place prescription lenses for the two eyes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLH	Pupillometer, Manual

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: 76b68098-45cb-414c-b88c-b1f83f04e1a4
Public Version Date: August 05, 2025
Public Version Number: 1
DI Record Publish Date: July 28, 2025