AccessGUDID - DEVICE: PASCAL Laser Indirect Ophthalmoscope (00855005006140)

GUDID

Device Identifier (DI) Information

Brand Name: PASCAL Laser Indirect Ophthalmoscope
Version or Model: LIO for PASCAL Photocoagulator 532
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SA-06201
Company Name: TOPCON MEDICAL LASER SYSTEMS, INC.

Primary DI Number: 00855005006140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041376321 *Terms of Use

Device Description: KIT, PASCAL LIO, GREEN, PASCAL B RELEASE

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?
32729	Indirect binocular laser ophthalmoscope	An electrically-powered, head-worn, ophthalmic device used for the stereoscopic examination and laser treatment of the eye, particularly the retina. It typically consists of a headband, a built-in light with aperture control for adjustment of the illumination field, convergence controls to synchronize the illumination and examination beams, a delivery mirror, filters to protect the surgeon against incidental laser-beam reflection, and a power-supply cable for the lighting, and a fibreoptic cable to convey the laser beam. This device is connected to an appropriate laser for delivery of laser energy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQF	Laser, ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123056	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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2088ec58-22a6-4fe1-949a-e0b96a24ce6e
Public Version Date: February 19, 2021
Public Version Number: 5
DI Record Publish Date: April 15, 2016