AccessGUDID - DEVICE: 3nethra (08908007754051)

GUDID

Device Identifier (DI) Information

Brand Name: 3nethra
Version or Model: neo P1000 control box
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FORUS HEALTH PRIVATE LIMITED

Primary DI Number: 08908007754051
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 864213893 *Terms of Use

Device Description: The 3nethra neo P1000 is a mydriatic digital imaging camera used for capturing and storing images of the human retina. The device acquires only digital photographs of the eye and does not provide any analysis or diagnosis. The 3nethra neo has a hand-held probe, a control unit, and a foot pedal. Components such as warm white LEDs, lenses, aperture, sensitive photodetector arrays (CMOS sensor array) are housed in the probe. The light emitted is within the safe limits of group 1 radiant exposure specifications for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the 15004-2 (and ANSI Z80.36-2016) Light Hazard Protection standards for Ophthalmic Instruments. 3nethra neo includes an application software that facilitates the capture, storage, and retrieval of images. Illumination and focus are adjusted using a foot pedal.

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

FDA Product Code

[?]

Product Code	Product Code Name
PJZ	Camera, Ophthalmic, General-Use

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: e612b8ec-565d-47c7-91d3-f32b41548500
Public Version Date: May 07, 2018
Public Version Number: 1
DI Record Publish Date: April 06, 2018