AccessGUDID - DEVICE: VISUCORE 500 Refractor (04250668606052)

GUDID

Device Identifier (DI) Information

Brand Name: VISUCORE 500 Refractor
Version or Model: 000000-2522-537
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000000-2522-537
Company Name: Carl Zeiss Vision GmbH

Primary DI Number: 04250668606052
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333928146 *Terms of Use

Device Description: No description.

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
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7e68a657-eba5-4b73-97cd-015f96fad6ca
Public Version Date: June 07, 2023
Public Version Number: 1
DI Record Publish Date: May 30, 2023