Home GUDID 00813125015602 PASCAL Synthesis, 532nm
Primary DI 00813125015602
Brand PASCAL Synthesis, 532nm
Company IRIDEX CORPORATION
Model PASCAL Synthesis 532- PA04
Catalog number SA-06454
Device description Pascal Synthesis III, PA-04, CB-8, 532 (Packed) IRIDEX
Published 2021-10-12
Public version status New
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 00813125015602 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 00813125015602 00813125015602 813125015602 0813125015602
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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 0 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 55 Degrees Celsius
Regulatory Flags# DUNS number 612920785 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00813125010249 Eye Safety Filter, Fixed (532 nm) 30775 2024-10-22 00813125010256 Eye Safety Filter, Fixed (532 nm) 31260 2024-10-22 00813125010263 Eye Safety Filter, Two-Position (532 nm) 30494 2024-10-22 00813125010270 Eye Safety Filter, Two-Position (532 nm) 30493 2024-10-22 00813125014490 Eye Safety Filter, Two-Position (577 nm) 65472 2024-10-22 00813125014506 Eye Safety Filter, Two-Position (577 nm) 65473 2024-10-22 00813125014513 Eye Safety Filter, Two-Position (532 nm) 65474 2024-10-22 00813125014520 Eye Safety Filter, Two-Position (532 nm) 65475 2024-10-22 00813125015039 Eye Safety Filter, Fixed (577 nm) 65551 2024-10-22 00813125017149 Eye Safety Filter, Fixed (532 nm) 30367 2024-10-22 00813125017163 Eye Safety Filter, Fixed (577 nm) 65470 2024-10-22 00813125017170 Eye Safety Filter, Fixed (577 nm) 65471 2024-10-22 00813125010188 Eye Safety Filter, Fixed (810 nm) 13107 2024-10-21 00813125010195 Eye Safety Filter, Fixed (810 nm) 14080 2024-10-21 00813125017118 Eye Safety Filter, Fixed (810 nm) 10378 2024-10-21 00813125017125 Eye Safety Filter, Fixed (810 nm) 11175 2024-10-21 00813125017132 Eye Safety Filter, Fixed (532 nm) 30366 2024-10-21 00813125017156 Eye Safety Filter, Fixed (532 nm) 30364 2024-10-21 00813125010584 OMA (810 nm) 13411 2024-05-06 00813125010591 OMA (810 nm) 11671 2024-05-06
Other Devices Sharing Product Codes# 
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