egger

Primary DI
EGOL206030
Brand
egger
Company
Egger Otoplastik + Labortechnik GmbH
Model
A/ITE
Published
2022-08-31
Public version status
New
Distribution status
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EGOL206041PrimaryHIBCC0
EGOL206030Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Earmould impression materialA rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328465042
Device count
8
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
EGOL206041eggerA/ITE2022-08-31
EGOL206171eggerA/soft S 502022-08-31
EGOL840851PHONAKC&C Wipe2023-01-01
EGOL840940PHONAKC&C Wipe2023-01-01
EGOL206001eggerA/soft2022-08-31
EGOL207001eggerflex/AB 40 shore, reddish-transparent2022-08-31
EGOL207021eggerflex/AB 40 shore, beige2022-08-31
EGOL207031eggerflex/AB 40 shore, red2022-08-31
EGOL207041eggerflex/AB 40 shore, blue2022-08-31
EGOL207071eggerflex/AB 40 shore, white2022-08-31
EGOL207081eggerflex/AB 40 shore, green2022-08-31
EGOL207091eggerflex/AB 40 shore, yellow2022-08-31
EGOL207161eggerflex/AB 40 shore, black2022-08-31
EGOL207181eggerflex/AB 40 shore, transparent2022-08-31
EGOL207191eggerflex/AB 40 shore, orange2022-08-31
EGOL207351eggerflex/AB 25 shore, transparent2022-08-31
EGOL208101eggerflex/AB 40 shore, reddish-transparent2022-08-31
EGOL208181eggerflex/AB 40 shore, transparent2022-08-31
EGOL208351eggerflex/AB 40 shore, pink2022-08-31
EGOL208361eggerflex/AB 40 shore, purple2022-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388201145STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201541STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201640AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201657AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201664AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201695NUEARStarkey Laboratories, Inc.ESD2025-06-25
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
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126191373AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191380AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191397AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191403AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191410AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191427AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191434AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191441AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191458AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191465AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191472AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191489AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191496AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191502AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191519AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191526AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191533AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191540AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191557AudinaAudina Hearing Instruments, Inc.ESD2023-01-31