Home GUDID 00855005006232 PASCAL Synthesis TwinStar
Primary DI 00855005006232
Brand PASCAL Synthesis TwinStar
Company TOPCON MEDICAL LASER SYSTEMS, INC.
Model PASCAL Synthesis TwinStar (577/638)- PA04
Catalog number SA-06452
Device description PASCAL Synthesis TwinStar (577/638), PA-04 (PACKED)
Published 2019-09-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name GEX Powered laser surgical instrument HQF Laser, ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEX Powered Laser Surgical Instrument General, Plastic Surgery 2 HQF Laser, Ophthalmic Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00855005006232 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00855005006232 00855005006232 855005006232 0855005006232
GMDN Terms# Term, Definition table Term Definition Ophthalmic solid-state laser system, photodisruption A mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended to cause a photodisruptive effect in the eye by forming a plasma and generating mechanical shock waves (microexplosions) that destroy tissue when highly focused (e.g., for cataract extraction, posterior capsulotomy). It typically includes a light source and controls/foot-switch and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors. It does not include femtosecond pulsing, frequency doubling, or fundus imaging technology.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 0 85 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 55 Degrees Celsius
Regulatory Flags# DUNS number 041376321 Device count 1 DM exempt true Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00855005006218 Head-Up-Display, HUD-1 Head-Up-Display,HUD-1 SA-06427 2018-02-12 00855005006102 PASCAL Laser Indirect Ophthalmoscope LIO for Streamline 532 SA-06161 2016-04-15 00855005006119 PASCAL Laser Indirect Ophthalmoscope LIO for Streamline 577 SA-06162 2016-04-15 00855005006126 PASCAL Laser Indirect Ophthalmoscope LIO for Synthesis 532 SA-06171 2016-04-15 00855005006133 PASCAL Laser Indirect Ophthalmoscope LIO for Synthesis 577 SA-06172 2016-04-15 00855005006140 PASCAL Laser Indirect Ophthalmoscope LIO for PASCAL Photocoagulator 532 SA-06201 2016-04-15 00855005006249 PACSAL Synthesis PASCAL Synthesis 532- PA04 SA-06454 2019-09-17 00855005006256 PASCAL Synthesis PASCAL Synthesis 577- PA04 SA-06455 2019-09-17 00855005006263 PASCAL Synthesis TwinStar PASCAL Synthesis TwinStar (577/638)- PA04 SA-06453 2019-09-17 00855005006270 PACSAL Synthesis PASCAL Synthesis 532- PA04 SA-06456 2019-09-17 00855005006287 PACSAL Synthesis PASCAL Synthesis 577- PA04 SA-06457 2019-09-17 00855005006003 PASCAL Synthesis PASCAL Synthesis 532 SA-06280 2016-04-15 00855005006010 PASCAL Synthesis PASCAL Synthesis 577 SA-06281 2016-04-15 00855005006027 PASCAL Synthesis PASCAL Synthesis 532 SA-06284 2016-04-15 00855005006034 PASCAL Synthesis PASCAL Synthesis 577 SA-06285 2016-04-15 00855005006041 PASCAL Synthesis Synthesis SLC & ESF 532 SA-06376 2016-04-15 00855005006058 PASCAL Synthesis Synthesis SLC & ESF 577 SA-06377 2016-04-15 00855005006065 PASCAL Synthesis Synthesis SLC & ESF 532 SA-06195 2016-04-15 00855005006072 PASCAL Synthesis Synthesis SLC & ESF 577 SA-06197 2016-04-15 00855005006089 PASCAL Synthesis Synthesis SLC & ESF 532 SA-06194 2016-04-15
Other Devices Sharing Product Codes# 
topcon.com