Home GUDID 00840516133027 Walcott Rx Products
Primary DI 00840516133027
Brand Walcott Rx Products
Company Psi/Eye-Ko, Inc.
Model Rx5008S
Device description Capsulorhexis Cystotome 25g X 16mm (5/8"), straight
Published 2023-08-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use 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 00840516134598 Primary GS1 0 00840516133027 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840516134598 00840516134598 840516134598 0840516134598 00840516133027 00840516133027 840516133027 0840516133027
GMDN Terms# Term, Definition table Term Definition Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use 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 or a basic handle (without controls). 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 single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 063763833 Device count 10 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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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