AccessGUDID - DEVICE: Medizs Auto Refractometer-Keratometer (08809358430291)

GUDID

Device Identifier (DI) Information

Brand Name: Medizs Auto Refractometer-Keratometer
Version or Model: RK-11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RK-11
Company Name: MEDIZS Inc.

Primary DI Number: 08809358430291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557804864 *Terms of Use

Device Description: Medizs Auto Refractometer-Keratometer RK-11 is a refraction device to measure Both of Refractometry & Keratometry. And also, it is able to take patient's PD, Axis and Cylinder value for a prescription of vision correction.

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?
36386	Automated ophthalmic refractometer	An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKO	Refractometer, Ophthalmic

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: 85525365-eb8d-45a7-81d7-2e70969c8660
Public Version Date: March 31, 2021
Public Version Number: 1
DI Record Publish Date: March 23, 2021