Home GUDID 00842180173286 ELMED
Primary DI 00842180173286
Brand ELMED
Company ELMED INCORPORATED
Model 13-906501
Catalog number 13-906501
Device description "Flynn scleral Depressor, 5mm Loop. lens style, Overall Length 3 1/8"" (8cm)"
Published 2024-04-17
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 00842180173286 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 00842180173286 00842180173286 842180173286 0842180173286
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 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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