AccessGUDID - DEVICE: IBEX Manual Refractor (00869228000465)

GUDID

Device Identifier (DI) Information

Brand Name: IBEX Manual Refractor
Version or Model: MR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Trevi Technology, Inc.

Primary DI Number: 00869228000465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078605507 *Terms of Use

Device Description: Manual Refractor is an ophthalmic testing device used to measure an individual’s refractive error and determine their eyeglass prescription.

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?
35299	Phoropter	An ophthalmic device intended to be placed in front of a patient's eyes to measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an ophthalmic examination, typically to determine a patient's prescription for glasses. It typically consists of two mounted, disk-like housings which contain lenses of different characteristics. It is designed such that the optometrist can change the lenses and other settings while asking the patient to read an eye chart and to provide subjective feedback on which settings give best vision. The setting changes may be manual or automated.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HKN	Refractor, Manual, Non-Powered, Including Phoropter

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: e98193e2-6431-4a34-9c43-ba476b257e58
Public Version Date: January 30, 2023
Public Version Number: 1
DI Record Publish Date: January 20, 2023