Home GUDID 00634782091705 Diagnostix™
Primary DI 00634782091705
Brand Diagnostix™
Company AMERICAN DIAGNOSTIC CORP
Model 5680L-56XEU
Catalog number 5680L-56XEU
Device description Adstation Oto+-L/Coax Oph-L,Derm/Throat-X, EU
Published 2018-02-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name ERA Otoscope HLJ Ophthalmoscope, Battery-Powered IBJ Light, Microscope
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ERA Otoscope Ear, Nose, Throat 1 HLJ Ophthalmoscope, Battery-Powered Ophthalmic 2 IBJ Light, Microscope Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00634782091705 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00634782091705 00634782091705 634782091705 0634782091705
GMDN Terms# Term, Definition table Term Definition Dermatoscope, optical An electrically-powered, hand-held instrument intended to be used for the direct microscopic examination of the external skin layers. The device has a built-in light source and magnification system that provides the user with the visualization of the structures of the epidermis and epidermal-dermal junction during dermatoscopy (also known as dermascopy). Oil may be applied to the skin to enhance skin transparency. This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 14 Degrees Fahrenheit 131 Degrees Fahrenheit
Regulatory Flags# DUNS number 108999095 Device count 1 Kit true Lot or batch 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 M368122731 Labtron GF HEALTH PRODUCTS, INC. HLJ 2020-09-22 M368122741 Labtron GF HEALTH PRODUCTS, INC. HLJ 2020-09-22 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 00192896009509 HEINE - BETA R HANDLE SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009516 HEINE - LITHIUM ION BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009523 HEINE MPACK MINI SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009530 HEINE MPACK LL BATTERY PACK SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009547 HEINE MPACK UNPLUGGED BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009554 HEINE MPACK UNPLUGGED BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009561 HEINE HC 50 CONNECTING CORD SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009578 HEINE MPACK SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009585 HEINE MPACK COMPLETE SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009592 HEINE LI-ION BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 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