Home GUDID 00851289007132 Firefly
Primary DI 00851289007132
Brand Firefly
Company Firefly Global
Model ES103
Device description Otoscope Specula
Published 2020-02-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name ERA Otoscope
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ERA Otoscope Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851289007132 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 00851289007132 00851289007132 851289007132 0851289007132
GMDN Terms# Term, Definition table Term Definition Otoscope, direct A portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable device.
Regulatory Flags# DUNS number 020089936 Device count 1 DM exempt true Premarket exempt true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 16972545090017 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-05-18 16972545090031 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-05-18 00050428029497 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ERA 2026-02-13 KTS0025716 K.T.Surgico K.T.SURGICO ERA 2024-07-24 00311917035000 Walgreens WALGREEN CO. ERA 2023-11-01 20884392954455 Safety 1st DOREL JUVENILE GROUP, INC. ERA 2023-10-15 10884389104514 Medline MEDLINE INDUSTRIES, INC. ERA 2023-01-21 10884389104521 Medline MEDLINE INDUSTRIES, INC. ERA 2023-01-21 17290018446154 Nonagon N9+ NONAGON LTD ERA 2022-09-28 27290018446151 Nonagon N9+ SmartExam NONAGON LTD ERA 2022-09-28 M368122711 LABTRON GF HEALTH PRODUCTS, INC. ERA 2020-09-15 H65811255271 Henry Schein HENRY SCHEIN, INC. ERA 2020-06-16 H65811255281 Henry Schein HENRY SCHEIN, INC. ERA 2020-06-16 10304040029203 Henry Schein HENRY SCHEIN, INC. ERA 2018-12-21 10304040029197 Henry Schein HENRY SCHEIN, INC. ERA 2018-09-24 10381780403234 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 10381780403289 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 10381780403869 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 10381780479369 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 00634782087753 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087760 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087777 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087784 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087791 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087807 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087814 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087821 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087838 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087845 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12 00634782087852 Diagnostix™ AMERICAN DIAGNOSTIC CORP ERA 2018-01-12