AccessGUDID - DEVICE: OPHTHALMOSCOPE (04987669100561)

GUDID

Device Identifier (DI) Information

Brand Name: OPHTHALMOSCOPE
Version or Model: F-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669100561
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The F-10 captures and records the confocal images of fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red. Indocyanine green (ICG) angiography and fluorescein angiography (FAG) are also possible.

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?
46787	Direct ophthalmoscope, line-powered	A mains electricity (AC-powered), hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of, a built-in light that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single hole through which the examiner will view, and a dial containing several lenses of different powers that can be alternated by the examiner whilst viewing. It produces an upright, or unreversed, image of approximately 15 times magnification. The power is run through a transformer to reduce this to low-voltage.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MYC	Ophthalmoscope, Laser, Scanning

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 3091c2ad-24bd-4c94-b662-9f7c14c6c796
Public Version Date: May 21, 2018
Public Version Number: 1
DI Record Publish Date: April 20, 2018