Home GUDID E23948271 Fotoplast® S IO
Primary DI E23948271
Brand Fotoplast® S IO
Company Dreve Otoplastik GmbH
Model 4827
Catalog number 4827
Device description No.
Published 2022-08-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 E23948271 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 18 Degrees Celsius 28 Degrees Celsius
Regulatory Flags# DUNS number 315808340 Device count 1 Premarket exempt true Lot or batch true Expiration 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 00840388201145 STARKEY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201541 STARKEY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201640 AUDIBEL Starkey Laboratories, Inc. ESD 2025-06-25 00840388201657 AUDIBEL Starkey Laboratories, Inc. ESD 2025-06-25 00840388201664 AUDIBEL Starkey Laboratories, Inc. ESD 2025-06-25 00840388201695 NUEAR Starkey Laboratories, Inc. ESD 2025-06-25 00840388201701 NUEAR Starkey Laboratories, Inc. ESD 2025-06-25 00840388201725 MICROTECH Starkey Laboratories, Inc. ESD 2025-06-25 00840388201732 MICROTECH Starkey Laboratories, Inc. ESD 2025-06-25 00840388201763 AUDIGY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201770 AUDIGY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201787 AUDIGY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201794 AUDIGY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201886 AMPLIFON Starkey Laboratories, Inc. ESD 2025-06-25 00840388201909 AMPLIFON Starkey Laboratories, Inc. ESD 2025-06-25 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 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
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