Home GUDID 00840516110752
Anodyne Surgical
Primary DI 00840516110752
Brand Anodyne Surgical
Company Psi/Eye-Ko, Inc.
Model 8215
Device description Push – Pull Manipulator angled
Published 2023-06-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name HNQ Hook, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HNQ Hook, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840516110752 Primary GS1 0 00840516107110 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 00840516110752 00840516110752 840516110752 0840516110752 00840516107110 00840516107110 840516107110 0840516107110
GMDN Terms# Term, Definition table Term Definition Ophthalmic surgical probe, single-use A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 063763833 Device count 10 Premarket exempt true Lot or batch true Expiration 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 04251047925849 Vera Fixation Hook A1 Medical GmbH HNQ 2026-05-29 00190776421151 Millennium Avalign Technologies, Inc. HNQ 2026-05-04 00190776420833 Millennium Avalign Technologies, Inc. HNQ 2026-04-30 00757770522750 Bausch + Lomb Bausch & Lomb Incorporated HNQ 2026-04-30 00757770636082 Bausch + Lomb Bausch & Lomb Incorporated HNQ 2026-04-30 00190776420086 Millennium Avalign Technologies, Inc. HNQ 2026-04-16 00190776420093 Millennium Avalign Technologies, Inc. HNQ 2026-04-16 00190776419912 Millennium Avalign Technologies, Inc. HNQ 2026-04-15 00190776414214 Millennium Avalign Technologies, Inc. HNQ 2025-10-22 00810163790447 Diamatrix Ltd. Diamatrix HNQ 2025-10-21 00810163790454 Diamatrix Ltd. Diamatrix HNQ 2025-10-21 00190776412616 Millennium Avalign Technologies, Inc. HNQ 2025-10-03 00190776412005 Millennium Avalign Technologies, Inc. HNQ 2025-10-01 G2231196790 Medetz Surgical Instruments Medetz Surgical Instruments LLC HNQ 2025-08-11 00810163790331 Diamatrix Ltd. Diamatrix HNQ 2025-05-27 10649111487934 Sklar Instruments SKLAR CORPORATION HNQ 2025-01-03 G2231196710 Medetz Surgical Instruments Medetz Surgical Instruments LLC HNQ 2023-09-19 00810123480883 Vortex Surgical Inc Vortex Surgical, Inc. HNQ 2023-02-02 00810123480890 Vortex Surgical Inc Vortex Surgical, Inc. HNQ 2023-02-02 00810123480906 Vortex Surgical Inc Vortex Surgical, Inc. HNQ 2023-02-02 00810123480913 Vortex Surgical Inc Vortex Surgical, Inc. HNQ 2023-02-02 G2231196700 Medetz Surgical Instruments Medetz Surgical Instruments LLC HNQ 2023-01-12 14026704790675 PILLING TELEFLEX INCORPORATED HNQ 2022-12-08 14026704799579 PILLING TELEFLEX INCORPORATED HNQ 2022-12-08 14026704799661 PILLING TELEFLEX INCORPORATED HNQ 2022-12-08 14026704799678 PILLING TELEFLEX INCORPORATED HNQ 2022-12-08 14026704799685 PILLING TELEFLEX INCORPORATED HNQ 2022-12-08 14026704799692 PILLING TELEFLEX INCORPORATED HNQ 2022-12-08 14026704799708 PILLING TELEFLEX INCORPORATED HNQ 2022-12-08 14026704799715 PILLING TELEFLEX INCORPORATED HNQ 2022-12-08