FDA.reportPublic FDA data

Phonak

Primary DI
07612847817678
Brand
Phonak
Company
Phonak AG
Model
050-0905-G5
Catalog number
050-0905-G5
Device description
Phonak Ambra microM (chili red)
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612847817678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612847817678076128478176787612847817678

GMDN Terms#

Term, Definition table
TermDefinition
Behind-the-ear air-conduction hearing aidA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41589280101contact@phonak.com

Regulatory Flags#

DUNS number
480089517
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
07613275528884Phonak058-0125-050058-0125-0502016-09-12
07612847809260Phonak050-0905-01050-0905-012016-09-12
07612847809277Phonak050-0906-01050-0906-012016-09-12
07612847809284Phonak050-0907-01050-0907-012016-09-12
07612847817517Phonak050-0905-13050-0905-132016-09-12
07612847817524Phonak050-0905-33050-0905-332016-09-12
07612847817531Phonak050-0905-34050-0905-342016-09-12
07612847817548Phonak050-0905-38050-0905-382016-09-12
07612847817555Phonak050-0905-70050-0905-702016-09-12
07612847817562Phonak050-0905-B3050-0905-B32016-09-12
07612847817579Phonak050-0905-B4050-0905-B42016-09-12
07612847817586Phonak050-0905-F0050-0905-F02016-09-12
07612847817609Phonak050-0905-F7050-0905-F72016-09-12
07612847817630Phonak050-0905-G1050-0905-G12016-09-12
07612847817647Phonak050-0905-G2050-0905-G22016-09-12
07612847817654Phonak050-0905-G3050-0905-G32016-09-12
07612847817661Phonak050-0905-G4050-0905-G42016-09-12
07612847818477Phonak050-0906-13050-0906-132016-09-12
07612847818484Phonak050-0906-33050-0906-332016-09-12
07612847818491Phonak050-0906-34050-0906-342016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880293531SIGNIAWs Audiology Usa, Inc.OSM2026-06-04
05714880297898SIGNIAWs Audiology Usa, Inc.OSM2026-06-04
06945936705688NewSoundXiamen New Sound Technology Co., Ltd.OSM2026-06-02
07613389836325DVD Phonak Target 12.0Sonova AGOSM2026-06-01
07613389836332USB Phonak Target 12.0 USBSonova AGOSM2026-06-01
07613389836349Phonak Target 12.0Sonova AGOSM2026-06-01
07613389842388Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842395Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842401Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389843026Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389917024Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917116Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917123Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
05714880113778CONNEXXWs Audiology Usa, Inc.OSM2026-05-28
05714880214345Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214611Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214628Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219425Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219432Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28