Home GUDID 16974308960001 Retone
Primary DI 16974308960001
Brand Retone
Company Xiamen Retone Hearing Technology Co., Ltd
Model K216
Published 2025-01-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name ESD Hearing Aid, Air-Conduction, Prescription
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 16974308960001 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 16974308960001 16974308960001
GMDN Terms# Term, Definition table Term Definition Air-conduction hearing aid, in-the-ear A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Regulatory Flags# DUNS number 544329913 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 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 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 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