Home GUDID B366OT101 OTOSCOPE
Primary DI B366OT101
Brand OTOSCOPE
Company Ecleris
Model R00
Catalog number OT101
Device description Otoscope, 2,7mm Ø, 0°, 75mm L
Published 2022-11-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 B366OT101 Primary HIBCC 0
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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 5 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -40 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 043555079 Device count 1 Premarket exempt true Serial number true Manufacturing date on label 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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