luxaprint 3D shell UV beige 500 g

Primary DI
EDET035381
Brand
luxaprint 3D shell UV beige 500 g
Company
DETAX GmbH
Model
03538
Published
2022-10-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air-Conduction, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDET035381PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Earmould, custom-madeA 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.

Regulatory Flags#

DUNS number
343947949
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDET037171luxaprint 3D mould UV clear 500g037172022-10-25
EDET037181luxaprint 3D mould UV rose 500g037182022-10-25
EDET037471freeprint shell beige 1000 g037472022-10-25
EDET039191freeprint shell black 1000 g039192022-10-25
EDET039461luxaprint 3D mould UV rose orange 1000 g039462022-10-25
EDET039731luxaprint 3D mould UV light beige 1000 g039732022-10-25
EDET040731medicalprint shell, white, 1000 g040732022-10-25
EDET038421luxaprint 3D shell white 500g038422024-08-28
EDET042461luxaprint flex UV 500 g042462022-10-26
EDET047491FREEPRINT crown A3,5 500g047492026-04-13
EDET047511FREEPRINT crown A3,5 1000g047512026-04-13
EDET047081FREEPRINT crown A3,5 1000g047082026-02-04
EDET047091FREEPRINT crown A3,5 500g047092026-02-04
EDET047541dx retainer 5 kg047542026-03-06
EDET047551dx retainer 1000g047552026-03-06
EDET030161medicalprint shell beige 2.0 1000g030162026-02-25
EDET042611Ultraprint-Dental Gingiva UV 1000g042612022-10-14
EDET045881VITA VIONIC® DENT RESIN A3,5 500 g045882026-02-04
EDET045891VITA VIONIC® DENT RESIN A3,5 1000 g045892026-02-04
EDET046341VITA VIONIC® BASE RESIN FLEX pink transparent 1000g046342026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613389772838ampli-mini I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772845ampli-mini I 2 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772920MEMINI I 4 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772937MEMINI I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
EDET038421luxaprint 3D shell white 500gDETAX GmbHESD2024-08-28
06945936704070NanoXiamen New Sound Technology Co., Ltd.ESD2024-05-21
06945936704087NanoXiamen New Sound Technology Co., Ltd.ESD2024-05-21
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
06945936703776NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126190000AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190017AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190024AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190031AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190048AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190055AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190062AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190079AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190086AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190093AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190109AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190116AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190123AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190130AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190147AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190154AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190161AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190178AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190185AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190192AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190208AudinaAudina Hearing Instruments, Inc.ESD2023-01-26