Home GUDID 00840516138473 Anodyne Surgical
Primary DI 00840516138473
Brand Anodyne Surgical
Company Psi/Eye-Ko, Inc.
Model 8402
Device description EYE SPECULUM (ADULT) [KRATZ]
Published 2024-02-09
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 HNC Specula, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HNC Specula, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840516138497 Package GS1 100 In Commercial Distribution 00840516138596 Package GS1 10 In Commercial Distribution 00840516138473 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 00840516138497 00840516138497 840516138497 0840516138497 00840516138596 00840516138596 840516138596 0840516138596 00840516138473 00840516138473 840516138473 0840516138473
GMDN Terms# Term, Definition table Term Definition Eyelid speculum, single-use A self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 063763833 Device count 1 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 00190776424046 Millennium Avalign Technologies, Inc. HNC 2026-08-27 00190776407452 Millennium Avalign Technologies, Inc. HNC 2026-07-31 G22312042490 Medetz Surgical Instruments Medetz Surgical Instruments LLC HNC 2026-07-27 00190776397074 Millennium Avalign Technologies, Inc. HNC 2026-07-16 00190776398682 Millennium Avalign Technologies, Inc. HNC 2026-07-16 00190776396770 Millennium Avalign Technologies, Inc. HNC 2026-07-14 G346E12710 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2026-06-23 00757770668540 Bausch + Lomb Bausch & Lomb Incorporated HNC 2026-06-22 00198506091513 ELMED INCORPORATED ELMED INCORPORATED HNC 2026-06-10 00198506091520 ELMED INCORPORATED ELMED INCORPORATED HNC 2026-06-10 04251047900174 Kratz-Barraquer Wire Speculum A1 Medical GmbH HNC 2026-05-29 04251047900655 Lieberman Eye Speculum A1 Medical GmbH HNC 2026-05-29 04251047900679 Lieberman Eye Speculum A1 Medical GmbH HNC 2026-05-29 04251047900686 Lieberman Eye Speculum A1 Medical GmbH HNC 2026-05-29 04251047932373 Mod. Krumeich Eye Speculum A1 Medical GmbH HNC 2026-05-29 08175700102636 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-10 08175700102643 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-10 08175700102650 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-10 08175700100489 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700100571 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700102605 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700102612 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 08175700102629 Ophthalmic Speculum AURORA SURGICAL, LLC HNC 2024-01-09 G346E12150 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2023-02-13 G346E1253R0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-19 G346E1254L0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-19 G346E1254R0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-19 G346E11250 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11260 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11440 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16
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