FDA.reportPublic FDA data

Phonak Brand

Primary DI
07613389275490
Brand
Phonak Brand
Company
Sonova AG
Model
056-3006-P8
Catalog number
056-3006-P8
Device description
Roger Focus II (velvet black)
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
07613389275490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389275490076133892754907613389275490

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
07613389840599Moxi S9-RX(velvet black)050-6927-P82026-07-26
07613389840605Moxi S9-RX(sand)050-6927-R82026-07-26
07613389842012Moxi S7-RX(amber beige)050-6926-P22026-07-26
07613389842029Moxi S7-RX(chestnut)050-6926-P42026-07-26
07613389842036Moxi S7-RX(silver gray)050-6926-P62026-07-26
07613389842043Moxi S7-RX(graphite gray)050-6926-P72026-07-26
07613389842050Moxi S7-RX(velvet black)050-6926-P82026-07-26
07613389842067Moxi S7-RX(sand)050-6926-R82026-07-26
07613389842074Moxi S9-RX(amber beige)050-6927-P22026-07-26
07613389842081Moxi S9-RX(chestnut)050-6927-P42026-07-26
07613389842098Moxi S9-RX(silver gray)050-6927-P62026-07-26
07613389842104Moxi S9-RX(graphite gray)050-6927-P72026-07-26
07613389842111Moxi S-RX FLEX:TRIAL(silver gray)050-6928-P62026-07-26
07613389843682Relate5.0 Platinum RIC RX(sand)050-6927-R8762026-07-26
07613389843699Relate5.0 RIC RX DEMO(silver gray)050-6928-P6762026-07-26
07613389844627Relate5.0 Gold RIC RX(chestnut)050-6926-P4762026-07-26
07613389844634Relate5.0 Gold RIC RX050-6926-P676050-6926-P6762026-07-26
07613389844641Relate5.0 Gold RIC RX(sand)050-6926-R8762026-07-26
07613389844658Relate5.0 Platinum RIC RX(chestnut)050-6927-P4762026-07-26
07613389844665Relate5.0 Platinum RIC RX(silver gray)050-6927-P6762026-07-26

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
07613389275445Phonak BrandSonova AGLZI2020-07-08
07613389275483Phonak 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