AccessGUDID - DEVICE: Zoom Slit Lamp (04562230695112)

GUDID

Device Identifier (DI) Information

Brand Name: Zoom Slit Lamp
Version or Model: NS-2D
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: RIGHT MFG. CO., LTD.

Primary DI Number: 04562230695112
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 713383495 *Terms of Use

Device Description: The NS-2D zoom slit lamps are designed for ophthalmic observation and microphotography. These slit lamps feature zoom stereoscopic converging microscope that can be used for ophthalmic observation. consisting of: Zoom Slit Lamp NS-2D Main Body with Imaging Unit(with Background Light) Eyepiece 12.5X for NS-2D Eyepiece 12.5X with Reticle for NS-2D Wooden Table top with Chin Rest for NS-2D Power supply for Illumination P-300N UL Power supply Cord Hospital Grade(120V) Dust Cover (Righton Logo) Righton NS File

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):	No
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?
35148	Ophthalmic examination slit lamp	An electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJO	Biomicroscope, Slit-Lamp, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110129	000

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
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Weight: 13 Kilogram
Height: 735 Millimeter
Depth: 405 Millimeter
Width: 330 Millimeter

Device Record Status

Public Device Record Key: af0520b1-8281-48ad-92f7-a9b9db930a2e
Public Version Date: June 13, 2023
Public Version Number: 6
DI Record Publish Date: July 13, 2016