Home GUDID 00190776371159 MILLENNIUM
Primary DI 00190776371159
Brand MILLENNIUM
Company Avalign Technologies, Inc.
Model 85-72048974
Device description Drews Cystotome,
Published 2023-09-28
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 HNY Cystotome
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HNY Cystotome Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776371159 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 00190776371159 00190776371159 190776371159 0190776371159
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 Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 792528510 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 00194613046149 MSI Precision Specialty Instruments Med Saver, Inc. HNY 2024-08-15 00840516141183 Anodyne Surgical Psi/Eye-Ko, 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 00840516116600 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116617 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116624 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116631 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116648 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116655 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116662 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116679 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116686 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116693 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116709 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116716 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116754 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116761 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116778 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116785 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116792 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116808 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116815 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116822 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116839 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116846 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116853 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28 00840516116860 Anodyne Surgical Psi/Eye-Ko, Inc. HNY 2023-08-28
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