AccessGUDID - DEVICE: CHART PROJECTOR (04987669100059)

GUDID

Device Identifier (DI) Information

Brand Name: CHART PROJECTOR
Version or Model: CP-770
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669100059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The NIDEK Chart Projector CP-770 is a test chart presenting device which can achieve refraction distance from 2.9 m to 6.1 m. The device is controlled by a wireless remote control or a control box on the refractor (RT). The CP-770 features the following: • Equipped with 33 types of charts (27 types for Type UK) including various kinds of binocular charts • Program function that allows chart presentation with the touch of a button • Versatile masking function that can even offer the display of even a single character • Chart brightness adjustability to the installation conditions • Switchable function between display and non-display of visual acuity of the chart • A long-life LED for the illumination light source

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?
35922	Visual acuity projector	A mains electricity (AC-powered) ophthalmic device intended to project an image on a screen to test visual acuity. The images typically include block letters (Snellen chart) and/or other symbols (e.g., recognizable objects used for children who cannot read) viewed in gradually decreasing size. They are typically identified according to the distance at which they are ordinarily visible (normally 6 metres or 20 feet).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOX	Chart, Visual Acuity

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: f41bb339-3ee6-4f6d-aeb1-2f4891e7ab64
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 10, 2016