Home GUDID KTS0025716 K.T.Surgico
Primary DI KTS0025716
Brand K.T.Surgico
Company K.T.SURGICO
Model 2024
Catalog number KTS0025716
Device description Otoscope
Published 2024-07-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use 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 MASTER90 Package HIBCC 50 Not in Commercial Distribution KTS0025716 Primary HIBCC 0 TMS1332504 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Otoscope, direct An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.
Regulatory Flags# DUNS number 645493024 Device count 50 Premarket exempt true Kit true Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05713315012341 Aurical Otocam 300-III Natus Medical Denmark ApS ERA 2026-07-20 06972545090485 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-07-17 16972545090154 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-07-17 04260154547271 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547400 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547417 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547424 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547448 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547455 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547462 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547479 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547486 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547493 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547530 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 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 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 00860003469828 hearX HEARX GROUP (PTY) LTD ERA 2022-05-30 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
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