AccessGUDID - DEVICE: REFRACTOR (04987669101445)

GUDID

Device Identifier (DI) Information

Brand Name: REFRACTOR
Version or Model: RT-6100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669101445
Issuing Agency: GS1
Commercial Distribution End Date: March 29, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The RT-6100 is a motorized refractor for subjective refraction designed to be connected with other Nidek products such as the Auto Refractometer and/or Lensmeter to import their measurement data. Measurement of refractive errors (spherical power, cylindrical power, and cylinder axis) and binocular visual function testing are performed according to the patient’s response.

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?
16800	Vision testing/training chart	An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.	Active	false
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
HOX	Chart, Visual Acuity
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: 8faf4599-8c2d-4b02-9e89-dca0c2ef7843
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: March 26, 2019