Home GUDID 00190660005443 Ambler Surgical
Primary DI 00190660005443
Brand Ambler Surgical
Company AMBLER SURGICAL CORP.
Model Kelman cystotome knife cannula
Catalog number 3422E
Device description Kelman cystotome knife cannula, 22 gauge, sharp double-edge, small size
Published 2021-01-04
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 00190660005443 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 00190660005443 00190660005443 190660005443 0190660005443
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 015272206 Device count 1 DM exempt true 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 00190660100360 Ambler Surgical Fiberoptic light cable 40-800 2021-01-04 00190660100377 Ambler Surgical Fiberoptic light cable 40-500 2021-01-04 00190660100384 Ambler Surgical Fiberoptic light cable 40-810 2021-01-04 00190660100391 Ambler Surgical Fiberoptic light cable 40-505 2021-01-04 00190660100407 Ambler Surgical Fiberoptic light cable 40-820 2021-01-04 00190660100414 Ambler Surgical Fiberoptic light cable 40-830 2021-01-04 00190660100421 Ambler Surgical Fiberoptic light cable 40-510 2021-01-04 00190660100438 Ambler Surgical Fiberoptic light cable 40-515 2021-01-04 00190660100445 Ambler Surgical Fiberoptic light cable 40-520 2021-01-04 00190660100452 Ambler Surgical Fiberoptic light cable 40-525 2021-01-04 00190660100469 Ambler Surgical Fiberoptic light cable 40-530 2021-01-04 00190660100476 Ambler Surgical Fiberoptic light cable 40-535 2021-01-04 00190660100483 Ambler Surgical Fiberoptic light cable 40-840 2021-01-04 00190660100490 Ambler Surgical Fiberoptic light cable 40-850 2021-01-04 00190660100506 Ambler Surgical Fiberoptic light cable 40-860 2021-01-04 00190660100513 Ambler Surgical Fiberoptic light cable 40-540 2021-01-04 00190660100520 Ambler Surgical Fiberoptic light cable 40-600 2021-01-04 00190660100537 Ambler Surgical Fiberoptic light cable 40-610 2021-01-04 00190660100544 Ambler Surgical Fiberoptic light cable 40-100 2021-01-04 00190660100551 Ambler Surgical Fiberoptic light cable 40-620 2021-01-04
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
amblersurgical.com