Home GUDID EDET033211 impression plugs, conical
Primary DI EDET033211
Brand impression plugs, conical
Company DETAX GmbH
Model 03321
Published 2022-10-25
Public version status Update
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, 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 EDET033211 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Earmould impression kit A collection of non-sterile supplies, instruments, and materials intended to be used to make an accurate impression of the folds and convolutions of cartilage that form the outer ear and its canal (i.e., an earmould). It typically includes a foam or cotton block, a mixing bowl, a spatula, impression liquid and/or powder; it also includes either a syringe or tube to deliver the impression material, or less frequently an impression tray for direct moulding. The mould of the ear is used to manufacture custom-made hearing devices such as hearing aids and earplugs. This is a single-use device.
Regulatory Flags# DUNS number 343947949 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published EDET047491 FREEPRINT crown A3,5 500g 04749 2026-04-13 EDET047511 FREEPRINT crown A3,5 1000g 04751 2026-04-13 EDET047081 FREEPRINT crown A3,5 1000g 04708 2026-02-04 EDET047091 FREEPRINT crown A3,5 500g 04709 2026-02-04 EDET047541 dx retainer 5 kg 04754 2026-03-06 EDET047551 dx retainer 1000g 04755 2026-03-06 EDET030161 medicalprint shell beige 2.0 1000g 03016 2026-02-25 EDET042611 Ultraprint-Dental Gingiva UV 1000g 04261 2022-10-14 EDET045881 VITA VIONIC® DENT RESIN A3,5 500 g 04588 2026-02-04 EDET045891 VITA VIONIC® DENT RESIN A3,5 1000 g 04589 2026-02-04 EDET046341 VITA VIONIC® BASE RESIN FLEX pink transparent 1000g 04634 2026-02-04 EDET046351 VITA VIONIC® BASE RESIN FLEX clear 1000g 04635 2026-02-04 EDET037151 luxaprint 3D mould UV red 500 g 03715 2022-10-25 EDET045581 medicalprint nobreak blue-transparent 1000g 04558 2025-12-22 EDET045631 medicalprint nobreak dark grey1000g 04563 2025-12-22 EDET045641 medicalprint nobreak green opaque 1000g 04564 2025-12-22 EDET045681 medicalprint nobreak dark neon yellow 1000g 04568 2025-12-22 EDET045691 medicalprint nobreak purple 1000g 04569 2025-12-22 EDET045701 medicalprint nobreak red-transparent 1000g 04570 2025-12-22 EDET045741 medicalprint nobreak white 1000g 04574 2025-12-22
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 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 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