Home GUDID 00813125011772 Illuminating Bayonet EndoProbe® Handpiece
Primary DI 00813125011772
Brand Illuminating Bayonet EndoProbe® Handpiece
Company IRIDEX CORPORATION
Model 65728-1
Published 2016-07-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GEX Powered Laser Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEX Powered Laser Surgical Instrument General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00813125011772 Package GS1 6 In Commercial Distribution 00813125011789 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 00813125011772 00813125011772 813125011772 0813125011772 00813125011789 00813125011789 813125011789 0813125011789
GMDN Terms# Term, Definition table Term Definition Ophthalmic laser system beam guide A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Needle Gauge 20 Gauge
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 612920785 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use 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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