FDA.reportPublic FDA data

Phonak Brand

Primary DI
07613275561584
Brand
Phonak Brand
Company
Sonova AG
Model
054-0768
Catalog number
054-0768
Device description
EasyView Otoblock M
Published
2021-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Contact Domains#

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
07613275561584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613275561584076132755615847613275561584

GMDN Terms#

Term, Definition table
TermDefinition
Earmould impression kitA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41589280101info@sonova.com

Regulatory Flags#

DUNS number
480662550
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613389915006SilentCloud Mobile App1.5.8088-0033-000102026-06-24
07613389938531SilentCloud Web App1.5.8088-0037-000102026-06-24
07613389860436Phonak Audéo E30-Sphere(Copper)050-1211-1A2026-03-17
07613389860443Phonak Audéo E30-Sphere(sienna red)050-1211-8A2026-03-17
07613389860450Phonak Audéo E30-Sphere(atlantic green)050-1211-9A2026-03-17
07613389860467Phonak Audéo E30-Sphere(beige)050-1211-H02026-03-17
07613389860474Phonak Audéo E30-Sphere(sand beige)050-1211-P12026-03-17
07613389860481Phonak Audéo E30-Sphere(sandalwood)050-1211-P32026-03-17
07613389860498Phonak Audéo E30-Sphere(chestnut)050-1211-P42026-03-17
07613389860504Phonak Audéo E30-Sphere(champagne)050-1211-P52026-03-17
07613389861419Phonak Audéo E30-Sphere(silver gray)050-1211-P62026-03-17
07613389861426Phonak Audéo E30-Sphere(graphite gray)050-1211-P72026-03-17
07613389861433Phonak Audéo E30-Sphere(velvet black)050-1211-P82026-03-17
07613389891461Phonak Audéo E30-Sphere(Caribbean Blue)050-1211-3C2026-03-17
07613389891478Phonak Audéo E30-Sphere(blue ocean)050-1211-M72026-03-17
07613389891485Phonak Audéo E30-Sphere(precious pink)050-1211-T32026-03-17
07613389836325DVD Phonak Target 12.012.0 DVD058-0125-1202026-06-01
07613389836332USB Phonak Target 12.0 USB12.0 USB058-0325-1202026-06-01
07613389836349Phonak Target 12.012.0088-0125-001202026-06-01
07613389842388Phonak ChargerGo ITEBULK075-01012026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388201145STARKEYStarkey 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
EDET038421luxaprint 3D shell white 500gDETAX GmbHESD2024-08-28
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
00810126191564AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191571AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191588AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191595AudinaAudina Hearing Instruments, Inc.ESD2023-01-31