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 EDET035381 luxaprint 3D shell UV beige 500 g 03538 2022-10-25 EDET037171 luxaprint 3D mould UV clear 500g 03717 2022-10-25 EDET037181 luxaprint 3D mould UV rose 500g 03718 2022-10-25 EDET037471 freeprint shell beige 1000 g 03747 2022-10-25 EDET039191 freeprint shell black 1000 g 03919 2022-10-25 EDET039461 luxaprint 3D mould UV rose orange 1000 g 03946 2022-10-25 EDET039731 luxaprint 3D mould UV light beige 1000 g 03973 2022-10-25 EDET040731 medicalprint shell, white, 1000 g 04073 2022-10-25 EDET038421 luxaprint 3D shell white 500g 03842 2024-08-28 EDET042461 luxaprint flex UV 500 g 04246 2022-10-26 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
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