AccessGUDID - DEVICE: ESSILOR SL300L (03615020000281)

GUDID

Device Identifier (DI) Information

Brand Name: ESSILOR SL300L
Version or Model: SL300L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ESSILOR INTERNATIONAL

Primary DI Number: 03615020000281
Issuing Agency: GS1
Commercial Distribution End Date: May 26, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 277373213 *Terms of Use

Device Description: Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes

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?
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 [?]
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
Storage Environment Temperature: between -40 and 55 Degrees Celsius
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Temperature: between -40 and 55 Degrees Celsius
Handling Environment Humidity: less than 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3701e504-2056-4fe8-af2d-90e67e4a9672
Public Version Date: July 26, 2023
Public Version Number: 5
DI Record Publish Date: September 23, 2016