Home GUDID 00840096200041 LASIK Flap Manipulator
Primary DI 00840096200041
Brand LASIK Flap Manipulator
Company KATALYST SURGICAL LLC
Model 8040
Published 2019-06-18
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 HND Spatula, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HND Spatula, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840096200041 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 00840096200041 00840096200041 840096200041 0840096200041
GMDN Terms# Term, Definition table Term Definition Ocular hook/spatula/manipulator, reusable A hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 007883297 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10817489027483 Laser Probe OS4, MultiFlex, 23ga VK400303 2019-03-19 10817489027490 Laser Probe OS4, MultiFlex, 25ga VK400305 2019-03-19 10817489027506 Laser Probe OS4, MultiFlex Inverted, 23ga VK400313 2019-03-19 10817489027513 Laser Probe OS4, MultiFlex Inverted, 25ga VK400315 2019-03-19 10817489027520 Laser Probe OS4, MultiFlex Extendable, 23ga VK400323 2019-03-19 10817489027544 Laser Probe OS4, MultiFlex Inverted Extendable, 23ga VK400333 2019-03-19 10817489027551 Laser Probe OS4, MultiFlex Inverted Extendable, 25ga VK400335 2019-03-19 10840096211235 20ga Straight Laser Probe 620200 2020-03-04 10840096211242 23ga Straight Laser Probe 620201 2020-03-04 10840096211259 25ga Straight Laser Probe 620202 2020-03-04 10840096211266 27ga Straight Laser Probe 620203 2020-03-04 10840096211273 23ga Flexible Curved Laser Probe 620210 2020-03-04 10840096211280 25ga Flexible Curved Laser Probe 620211 2020-03-04 10840096211297 27ga Flexible Curved Laser Probe 620212 2020-03-04 10840096211303 20ga Illuminated Straight Laser Probe 620220 2020-03-04 10840096211310 23ga Illuminated Straight Laser Probe 620221 2020-03-04 10840096211327 25ga Illuminated Straight Laser Probe 620222 2020-03-04 10840096211334 27ga Illuminated Straight Laser Probe 620223 2020-03-04 10840096211341 23ga Illuminated Flexible Curved Laser Probe 620229 2020-03-04 10840096211358 25ga Illuminated Flexible Curved Laser Probe 620230 2020-03-04
Other Devices Sharing Product Codes#