Home GUDID 00732094103595 Welch Allyn, Inc.
Primary DI 00732094103595
Brand Welch Allyn, Inc.
Company WELCH ALLYN, INC.
Model 901026
Catalog number 97151-MS
Device description Welch Allyn 3.5 V Halogen HPX Diagnostic Set including Standard Ophthalmoscope (#11710), MacroView Otoscope (#23810), Rechargeable 1 20-Minute Power Handle(s), Soft Storage Case; Lithium-Ion (#71960) Battery; IEC Plug Type-A
Published 2016-09-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 00732094103595 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 00732094103595 00732094103595 732094103595 0732094103595
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.
Regulatory Flags# DUNS number 198227881 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00732094322866 Welch Allyn, Inc. 901134 ESCRIBE-CAX-DXACB 2019-07-22 00732094322873 Welch Allyn, Inc. 901134 ESCRIBE-CAX-CXXXX 2019-07-22 00732094322880 Welch Allyn, Inc. 901134 ESCRIBE-CAX-CXACX 2019-07-22 00732094322897 Welch Allyn, Inc. 901134 ESCRIBE-CAX-CXACA 2019-07-22 00732094322903 Welch Allyn, Inc. 901134 ESCRIBE-BEX-CXXXA 2019-07-22 00732094322910 Welch Allyn, Inc. 901134 ESCRIBE-BEX-CXXCA 2019-07-22 00732094322927 Welch Allyn, Inc. 901134 ESCRIBE-BEX-CXACA 2019-07-22 00732094322934 Welch Allyn, Inc. 901134 ESCRIBE-BEX-CXAAA 2019-07-22 00732094322941 Welch Allyn, Inc. 901134 ESCRIBE-BAX-DXACX 2019-07-22 00732094322958 Welch Allyn, Inc. 901134 ESCRIBE-BAX-DXACB 2019-07-22 00732094322965 Welch Allyn, Inc. 901134 ESCRIBE-BAX-CXXXX 2019-07-22 00732094322972 Welch Allyn, Inc. 901134 ESCRIBE-BAX-CXACB 2019-07-22 00732094322989 Welch Allyn, Inc. 901134 ESCRIBE-BAX-CXACA 2019-07-22 00732094322996 Welch Allyn, Inc. 901134 ESCRIBE-BAX-CXAAX 2019-07-22 00732094323009 Welch Allyn, Inc. 901134 ESCRIBE-AEX-CXXXX 2019-07-22 00732094323016 Welch Allyn, Inc. 901134 ESCRIBE-AEX-CXXXA 2019-07-22 00732094323023 Welch Allyn, Inc. 901134 ESCRIBE-AEX-CXAXA 2019-07-22 00732094323030 Welch Allyn, Inc. 901134 ESCRIBE-AEX-CXAAA 2019-07-22 00732094323047 Welch Allyn, Inc. 901134 ESCRIBE-AAX-DXXXX 2019-07-22 00732094323054 Welch Allyn, Inc. 901134 ESCRIBE-AAX-CXXXX 2019-07-22
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