Home GUDID 00840096200133 Titanium Genisi LASIK Speculum
Primary DI 00840096200133
Brand Titanium Genisi LASIK Speculum
Company KATALYST SURGICAL LLC
Model 7017
Published 2019-06-19
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HNC Specula, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HNC Specula, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840096200133 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 00840096200133 00840096200133 840096200133 0840096200133
GMDN Terms# Term, Definition table Term Definition Eyelid speculum, reusable A self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. This is a reusable device.
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 00817489022023 25ga Dex™ Serrated Jaw Forceps DVF4016-25 2016-08-11 00817489022146 25ga Dex™ Maculorhexis Forceps DVF4019-25 2016-08-11 00840096207606 DEX TIPS™ Universal Handle CV-Handle 2020-06-08 00840096207613 DEX TIPS™ Universal Slim Handle CVO-Handle 2020-06-08 10840096211365 Cili Probes (Cyclophotocoagulation) 620231 2020-03-04 10817489025298 Cyclophotocoagulation Probe, Quantel Connector XLCYCLO 2018-12-11 10817489025304 Cyclophotocoagulation Probe, Iridex Connector XLCYCLOA 2018-12-11 10817489025151 Ciliprobe Transsceral Cyclophotocoagulation Probe D4700A 2017-07-21 10817489025168 Ciliprobe Transsceral Cyclophotocoagulation Probe D4700C 2017-07-21 10840096215325 27ga Stiff Slim DEX™ NanoTapered™ Awh Forceps DVFO4005-27 2025-10-06 00840096214987 Curved Up Micro Scissors, 11mm Blades, Bayonet Round Handle, 230mm N6106 2025-09-10 10817489023560 20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex V6300-20AR 2020-11-25 10817489023577 20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Alcon V6300-20BR 2020-11-27 10817489023584 20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Quantel V6300-20CR 2020-11-27 10817489023591 20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Nidek V6300-20ER 2020-11-27 10817489023607 20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORC V6300-20JR 2020-11-27 10817489023614 23ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex V6300-23AR 2020-11-25 10817489023621 23ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Alcon V6300-23BR 2020-11-27 10817489023638 23ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Quantel V6300-23CR 2020-11-27 10817489023645 23ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Nidek V6300-23ER 2020-11-27
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08175700102636 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-10 08175700102643 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-10 08175700102650 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-10 08175700100489 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700100571 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700102605 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700102612 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700102629 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 G346E12150 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2023-02-13 G346E1253R0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-19 G346E1254L0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-19 G346E1254R0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-19 G346E11250 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11260 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11440 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11490 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11560 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12010 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12020 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12030 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12050 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12060 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12070 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12100 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12210 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E1230 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E1253L0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12650 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E145K0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E1460 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16