Home GUDID 00198506090912 ELMED INCORPORATED
Primary DI 00198506090912
Brand ELMED INCORPORATED
Company ELMED INCORPORATED
Model 35-62914
Catalog number 35-62914
Device description "DASTOOR PUPIL AND IRIS REPOSITOR, DOUBLE ENDED 1MM WIDE, NOTCHED TIP AND SPATULA SHAPED TIP, OL 13CM (5"")"
Published 2026-05-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00198506090912 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 00198506090912 00198506090912 198506090912 0198506090912
GMDN Terms# Term, Definition table Term Definition Ophthalmic surgical procedure kit, non-medicated, reusable A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 049290364 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label 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 G346E145K0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16 G346E1460 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HNC 2022-12-16
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