Home GUDID M368122712 LABTRON
Primary DI M368122712
Brand LABTRON
Company GF HEALTH PRODUCTS, INC.
Model 1227-1
Device description Otoscope Set
Published 2020-09-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false 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 M368122712 Package HIBCC 20 In Commercial Distribution M368122711 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Otoscope, direct A portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. This is a reusable device.
Regulatory Flags# DUNS number 132016168 Device count 1 DM exempt false Premarket exempt true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 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 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 10381780403289 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16 10381780403869 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION ERA 2018-08-16
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