FDA.reportPublic FDA data

Phonak Brand

Primary DI
07613389275445
Brand
Phonak Brand
Company
Sonova AG
Model
056-3006-M8
Catalog number
056-3006-M8
Device description
Roger Focus II (majesty purple)
Published
2020-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZIDevice, assistive listening

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZIDevice, Assistive ListeningEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613389275445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389275445076133892754457613389275445

GMDN Terms#

Term, Definition table
TermDefinition
Attention assistive training deviceA device designed to be used by a person with a disability to develop their ability to concentrate.

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07613389842395Phonak ChargerGo ITEno EPS075-0101-102026-06-01
07613389842401Phonak ChargerGo ITEUS EPS075-0101-112026-06-01
07613389843026Phonak ChargerGo ITEB3075-0101-030B32026-06-01
07613389917024Phonak ChargerGo RIC I ENO EPS075-0108-102026-06-01
07613389917116Phonak ChargerGo RIC I EUS EPS075-0108-112026-06-01
07613389917123Phonak ChargerGo RIC I EUS EPS VA075-0108-110902026-06-01
07613389540031Sonova Brand (multiple brand)051-5047-AB2022-12-12
07613389564228Sonova Brand (multiple brand)051-5046-AB2022-12-12
07613389619621Sonova Brand (multiple brand)051-5107-AB2022-12-12
07613389557930All-Day Clear 1.0 app088-5015088-50152023-02-16
07613389771831MEMINI E D 6P R-R PH (silver gray)050-1145-P6B12026-03-26
07613389771855MEMINI E D 6P R-R AI PH (silver gray)050-1147-P6B12026-03-26
07613389772012ampli-mini E 2 6P R-R PH (velvet black)050-1137-P8672026-03-26
07613389772401MEMINI E 2 6P R-R PH (silver gray)050-1137-P6B12026-03-26
07613389772418MEMINI E 2 6P R-R PH (velvet black)050-1137-P8B12026-03-26
07613389772548MEMINI E 5 6P R-R AI PH (sand beige)050-1141-P1B12026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613389274165Phonak BrandSonova AGLZI2020-07-08
07613389275414Phonak BrandSonova AGLZI2020-07-08
07613389275421Phonak BrandSonova AGLZI2020-07-08
07613389275438Phonak BrandSonova AGLZI2020-07-08
07613389275483Phonak BrandSonova AGLZI2020-07-08
07613389275490Phonak BrandSonova AGLZI2020-07-08
07613389275506Phonak BrandSonova AGLZI2020-07-08
07613389275513Phonak BrandSonova AGLZI2020-07-08
07613389275520Phonak BrandSonova AGLZI2020-07-08
07613389275537Phonak BrandSonova AGLZI2020-07-08
07613389275674Phonak BrandSonova AGLZI2020-07-08