Home GUDID 00634782587888 Diagnostix™
Primary DI 00634782587888
Brand Diagnostix™
Company AMERICAN DIAGNOSTIC CORP
Model 5111NLSG
Catalog number 5111NLSG
Device description DIAGNOSTIX Pocket Otoscope,2.5v, LED, Soft, Gray
Published 2017-11-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 00634782587888 Package GS1 4 In Commercial Distribution 00634782086466 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 00634782587888 00634782587888 634782587888 0634782587888 00634782086466 00634782086466 634782086466 0634782086466
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 Temperature -4 Degrees Fahrenheit 120.2 Degrees Fahrenheit
Regulatory Flags# DUNS number 108999095 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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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