Home GUDID G346E145K0 Epsilon USA
Primary DI G346E145K0
Brand Epsilon USA
Company EPSILON EYE CARE PRIVATE LIMITED
Model E1-45K
Device description "Pediatric Speculum Wire Type Closed Wire ""K"" (28mm Overall) Stainless Steel"
Published 2022-12-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 G346E145K0 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"", ""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Regulatory Flags# DUNS number 917922762 Device count 1 Premarket exempt 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 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 G346E12070 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12100 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12210 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E1230 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E1253L0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E12650 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E1460 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E146B0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16