AccessGUDID - DEVICE: MediWorks (06945087500064)

GUDID

Device Identifier (DI) Information

Brand Name: MediWorks
Version or Model: V101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.

Primary DI Number: 06945087500064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 527884077 *Terms of Use

Device Description: The vision screening instrument is based on the principle of eccentric photo refraction and is used for screening myopia, hyperopia and astigmatism. Refraction, eye position, pupil, pupil distance and other information can be obtained for doctors to diagnose eye diseases.

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":	Yes
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?
65244	Hand-held subjective ophthalmic refractometer	A hand-held ophthalmic device intended to be used by a layperson to measure the refractive error of their eye (the inaccuracies of focusing light upon the retina), typically to test their vision. It is typically in the form of a monocular which contains lenses of different characteristics; a dedicated software providing examination protocols may also be included. The patient changes the lenses and other settings while reading an eye chart to subjectively evaluate which settings give best 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: 3af79022-9e55-4dd0-911e-1f1b90be68c6
Public Version Date: November 11, 2022
Public Version Number: 1
DI Record Publish Date: November 03, 2022