Home GUDID 04250480107331 PrimeSight
Primary DI 04250480107331
Brand PrimeSight
Company SCHÖLLY FIBEROPTIC GmbH
Model 02-4305
Device description Otoscope 2.7 x 34 mm, 0°
Published 2016-12-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx 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 04250480107331 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04250480107331 04250480107331 4250480107331
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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 316276682 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 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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