Home GUDID E2397100ST1 FotoTec® SL.A
Primary DI E2397100ST1
Brand FotoTec® SL.A
Company Dreve Otoplastik GmbH
Model 7100ST
Catalog number 7100ST
Device description No.
Published 2022-08-12
Public version status Update
Distribution status Not 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 ESD Hearing aid, air conduction
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ESD Hearing Aid, Air-Conduction, Prescription Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status E2397100ST1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Earmould, custom-made A custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from sunlight Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 315808340 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 true 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 07613389772838 ampli-mini I 3 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 07613389772845 ampli-mini I 2 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 07613389772920 MEMINI I 4 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 07613389772937 MEMINI I 3 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 EDET038421 luxaprint 3D shell white 500g DETAX GmbH ESD 2024-08-28 16945936703773 Newsound Xiamen New Sound Technology Co., Ltd. ESD 2024-01-19 00810126191373 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191380 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191397 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191403 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191410 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191427 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191434 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191441 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191458 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191465 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191472 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191489 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191496 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191502 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191519 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191526 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191533 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191540 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191557 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191564 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191571 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191588 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191595 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191601 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31
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