Home GUDID 00850013784134 OtoSight Middle Ear Scope with Battery
Primary DI 00850013784134
Brand OtoSight Middle Ear Scope with Battery
Company Photonicare, Inc.
Model 34R
Device description The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults.
Published 2023-08-20
Public version status New
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 QJG Device System, Imaging, Tympanic Membrane And Middle Ear
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QJG Device System, Imaging, Tympanic Membrane And Middle Ear Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850013784134 Package GS1 1 In Commercial Distribution 00850013784158 Package GS1 1 In Commercial Distribution 00850013784127 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 00850013784134 00850013784134 850013784134 0850013784134 00850013784158 00850013784158 850013784158 0850013784158 00850013784127 00850013784127 850013784127 0850013784127
GMDN Terms# Term, Definition table Term Definition Otoscope, endoscopic An endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.
Regulatory Flags# DUNS number 078873691 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850013784004 OtoSight Middle Ear Scope 34R 2022-04-15 00850013784127 OtoSight Middle Ear Scope with Battery 34R 2023-08-20 10850013784070 Large OtoSight Speculum Tip QTY 20 Large 2022-04-15 00850013784110 OtoSight Speculum Tip Combination Package Combo 2022-04-15 00850013784097 Large OtoSight Speculum Tip QTY 20 Large 2022-04-15 10850013784087 Standard Otosight Speculum Tip QTY 20 Standard 2022-04-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850013784127 OtoSight Middle Ear Scope with Battery Photonicare, Inc. QJG 2023-08-20 10850013784070 Large OtoSight Speculum Tip QTY 20 Photonicare, Inc. QJG 2022-04-15 00850013784004 OtoSight Middle Ear Scope Photonicare, Inc. QJG 2022-04-15 00850013784110 OtoSight Speculum Tip Combination Package Photonicare, Inc. QJG 2022-04-15 00850013784097 Large OtoSight Speculum Tip QTY 20 Photonicare, Inc. QJG 2022-04-15 10850013784087 Standard Otosight Speculum Tip QTY 20 Photonicare, Inc. QJG 2022-04-15
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