Home GUDID 00634782087043 Diagnostix™
Primary DI 00634782087043
Brand Diagnostix™
Company AMERICAN DIAGNOSTIC CORP
Model 5120NV
Catalog number 5120NV
Device description Head, 2.5v DIAGNOSTIX Otoscope,Hal/Xen, Purple
Published 2019-05-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC 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 00634782087043 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 00634782087043 00634782087043 634782087043 0634782087043
GMDN Terms# Term, Definition table Term Definition Ophthalmic/otologic diagnostic set A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 0 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -4 Degrees Fahrenheit 120.2 Degrees Fahrenheit
Regulatory Flags# DUNS number 108999095 Device count 1 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
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