Home GUDID G346E12710 Epsilon USA
Primary DI G346E12710
Brand Epsilon USA
Company EPSILON EYE CARE PRIVATE LIMITED
Model E1-271
Device description Davidson "V" Eye Speculum Round Arms Temporal Bend 10.50 mm Blades Titanium
Published 2026-06-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false 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 G346E12710 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Eyelid speculum, reusable A self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic 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 and is usually made of stainless steel. This is a reusable device.
Sterilization Methods# Method table Method Dry Heat Sterilization Ethylene Oxide Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 917922762 Device count 1 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 false 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 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 G346E11490 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E11560 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12010 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12020 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12030 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12050 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12060 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16