Home GUDID 00813628084938 Walker's®
Primary DI 00813628084938
Brand Walker's®
Company HEARING LAB TECHNOLOGY, LLC
Model FS
Catalog number HLT-CUSFS-64
Device description Custom Full Shell 64
Published 2018-09-21
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true 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 00813628084938 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 00813628084938 00813628084938 813628084938 0813628084938
GMDN Terms# Term, Definition table Term Definition In-the-ear air-conduction hearing aid 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 827693503 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false 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 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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