Home GUDID 00192896012561 GRAEFE CYSTOTOME
Primary DI 00192896012561
Brand GRAEFE CYSTOTOME
Company SONTEC INSTRUMENTS, INC.
Model 11-1800
Catalog number 11-1800
Device description GRAEFE CYSTOTOME
Published 2018-09-18
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 EMF KNIFE, SURGICAL HNY Cystotome
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMF Knife, Surgical General, Plastic Surgery 1 HNY Cystotome Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00192896012561 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 00192896012561 00192896012561 192896012561 0192896012561
GMDN Terms# Term, Definition table Term Definition Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method "[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]" Dry Heat Sterilization;Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 040729840 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198506085659 ELMED INCORPORATED ELMED INCORPORATED EMF 2025-10-02 10888277370647 MEDLINE MEDLINE INDUSTRIES, INC. EMF 2025-02-14 10888277377615 MEDLINE MEDLINE INDUSTRIES, INC. EMF 2025-01-21 00194613046149 MSI Precision Specialty Instruments Med Saver, Inc. HNY 2024-08-15 08052276012432 Irrigating Cystotome Ang.45° 27Gx16mm AKTIVE SRL HNY 2023-12-19 08052276012937 Irrigating Cystotome Formed 27G x 16mm AKTIVE SRL HNY 2023-12-19 08052276012968 Irrigating Cystotome Ang.45° 25G x16 mm AKTIVE SRL HNY 2023-12-19 00840516105345 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-10-10 00840516109077 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109084 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109091 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109107 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109114 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109121 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109138 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109145 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109152 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109169 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109176 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109183 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109190 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109206 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109213 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109220 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109237 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109244 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109251 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109268 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109275 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14 00840516109282 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-06-14
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