FDA.reportPublic FDA data

Phonak

Primary DI
07613275537633
Brand
Phonak
Company
Sonova AG
Model
050-0277-P6
Catalog number
050-0277-P6
Device description
Phonak Audeo B50-Direct (silver gray)
Published
2017-08-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, tinnitus
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613275537633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613275537633076132755376337613275537633

Contacts#

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

Regulatory Flags#

DUNS number
480662550
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
07613389927696Phonak CROS E-R(beige)050-1144-H0B32026-08-03
07613389927719Phonak CROS E-R(sand beige)050-1144-P1B32026-08-03
07613389927726Phonak CROS E-R(sandalwood)050-1144-P3B32026-08-03
07613389927733Phonak CROS E-R(chestnut)050-1144-P4B32026-08-03
07613389927740Phonak CROS E-R(champagne)050-1144-P5B32026-08-03
07613389927757Phonak CROS E-R(silver gray)050-1144-P6B32026-08-03
07613389927764Phonak CROS E-R(graphite gray)050-1144-P7B32026-08-03
07613389927771Phonak CROS E-R(velvet black)050-1144-P8B32026-08-03
07613389928181Phonak CROS E-R(sienna red)050-1144-8AB32026-08-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880288629WSAWs Audiology Usa, Inc.OSM2026-11-04
05714880294392CONNEXXWs Audiology Usa, Inc.OSM2026-11-04
05714880297416WSAWs Audiology Usa, Inc.OSM2026-11-04
05714880297881CONNEXXWs Audiology Usa, Inc.OSM2026-11-04
05714880300390WSAWs Audiology Usa, Inc.OSM2026-11-04
05714880300116TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300116TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300123TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300123TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300130TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300130TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300147TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300147TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880296181WidexWidex A/SKLW2026-10-30
05714880296181WidexWidex A/SOSM2026-10-30
05714880296198WidexWidex A/SKLW2026-10-30
05714880296198WidexWidex A/SOSM2026-10-30
05714880296204WidexWidex A/SKLW2026-10-30
05714880296204WidexWidex A/SOSM2026-10-30
05714880296211WidexWidex A/SKLW2026-10-30
05714880296211WidexWidex A/SOSM2026-10-30
05714880296228WidexWidex A/SKLW2026-10-30
05714880296228WidexWidex A/SOSM2026-10-30
05714880296235WidexWidex A/SKLW2026-10-30
05714880296235WidexWidex A/SOSM2026-10-30
05714880296242WidexWidex A/SKLW2026-10-30
05714880296242WidexWidex A/SOSM2026-10-30
05714880296259WidexWidex A/SKLW2026-10-30
05714880296259WidexWidex A/SOSM2026-10-30
05714880296266WidexWidex A/SKLW2026-10-30