Home GUDID 00840516136851
Anodyne Surgical
Primary DI 00840516136851
Brand Anodyne Surgical
Company Psi/Eye-Ko, Inc.
Model 5012
Device description "STROMAL PUNCTURE NEEDLE 25g X 1"""
Published 2023-08-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00840516136868 Package GS1 50 In Commercial Distribution 00840516136875 Package GS1 500 In Commercial Distribution 00840516136851 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 00840516136868 00840516136868 840516136868 0840516136868 00840516136875 00840516136875 840516136875 0840516136875 00840516136851 00840516136851 840516136851 0840516136851
GMDN Terms# Term, Definition table Term Definition General-purpose endoscopic needle, single-use A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.
Sterilization Methods# Method table Method "[""Ethylene Oxide"", ""Radiation Sterilization""]"
Regulatory Flags# DUNS number 063763833 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true No natural rubber latex 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