Home GUDID 00850013784097 Large OtoSight Speculum Tip QTY 20
Primary DI 00850013784097
Brand Large OtoSight Speculum Tip QTY 20
Company Photonicare, Inc.
Model Large
Device description 20 pack of Large OtoSight Speculum Tips
Published 2022-04-15
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 true 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 00850013784097 Package GS1 10 In Commercial Distribution 10850013784070 Primary GS1 0 00850013784073 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850013784097 00850013784097 850013784097 0850013784097 10850013784070 10850013784070 00850013784073 00850013784073 850013784073 0850013784073
GMDN Terms# Term, Definition table Term Definition Ear speculum, single-use A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.
Regulatory Flags# DUNS number 078873691 Device count 20 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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 00850013784134 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 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 00850013784134 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 10850013784087 Standard Otosight Speculum Tip QTY 20 Photonicare, Inc. QJG 2022-04-15