AccessGUDID - DEVICE: Scanning Laser Ophthalmoscope (04987669101568)

GUDID

Device Identifier (DI) Information

Brand Name: Scanning Laser Ophthalmoscope
Version or Model: Mirante
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669101568
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The Nidek Mirante Scanning Laser Ophthalmoscope is an ophthalmic imaging device that allows non invasive and non-contact observation of the shape and the disease state of the fundus, anterior segment, and retina using a scanning laser ophthalmoscope (hereafter referred to as “SLO”) and/or optical coherence tomography (hereafter referred to as “OCT”).

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?
47952	Scanning-laser retinal imaging system	An assembly of electrically-powered ophthalmic instruments and digital image capturing/processing devices intended to use a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of chorioditis.	Active	false
46799	Retinal optical coherence tomography system	An assembly of devices that uses a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement of the retina, the retinal nerve fibre layer (its thickness), and optic disk in order to diagnose and manage retinal diseases. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional images of the retina or three-dimensional (3-D) volume scans. Optical coherence tomography (OCT) is used for visualizing the area/location of retinal-thickness abnormalities, macular holes or oedema, atrophy associated with degenerative diseases, glaucoma, and other retinal pathologies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBO	Tomography, Optical Coherence
MYC	Ophthalmoscope, Laser, Scanning
NFJ	System, Image Management, Ophthalmic

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: 06fcfd7d-c27a-4405-95e4-2b2b77781832
Public Version Date: April 03, 2024
Public Version Number: 2
DI Record Publish Date: June 12, 2023