AccessGUDID - DEVICE: MICROPERIMETER (04987669101544)

GUDID

Device Identifier (DI) Information

Brand Name: MICROPERIMETER
Version or Model: MP-3 type S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669101544
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The NIDEK MICROPERIMETER, MP-3 measures the visual sensitivity of a specified area on the fundus according to the patient’s response, and captures color fundus images. The fundus image overlaid with the retinal sensitivity mapping is displayed on the screen for fundus-image-correlated evaluation. With reference to the Microperimeter MP-3, a rehabilitation function and the capability to performs exams in scotopic environments (only MP-3 type S) have been added.

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?
10551	Ophthalmic fundus camera	An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.	Active	false
16918	Perimeter, automatic	A mains electricity (AC-powered), automatically operated, diagnostic, ophthalmic instrument intended for assessing the extent of the patient's peripheral visual field. Small luminous points (spots) are automatically displayed in various random positions and patient response is automatically recorded. The print-out (chart) then shows the resulting curve of the visual field. Such types include Humphrey perimeters.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKI	Camera, Ophthalmic, Ac-Powered
HPT	Perimeter, Automatic, Ac-Powered

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: 9887bde8-bf49-4148-834e-48552ea8f132
Public Version Date: June 20, 2023
Public Version Number: 1
DI Record Publish Date: June 12, 2023