FDA.reportPublic FDA data

Phonak

Primary DI
07612904393831
Brand
Phonak
Company
Sonova AG
Model
052-3113-X02P59
Catalog number
052-3113-X02P59
Device description
Roger X (02) (champagne)
Published
2018-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
07612904393831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612904393831076129043938317612904393831

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid enhanced audio device, teaching-environmentA collection of battery-powered devices designed to be worn by a person (typically a child) wearing a compatible hearing aid to enhance the sound quality they receive by reducing background noise and/or room reverberation potentially found in a teaching environment (e.g., a school classroom). It uses a set frequency modulation (FM) between a transmitter worn by the speaker (e.g., a microphone worn be the teacher) and the FM receiver worn by the user. It typically consists of the FM receiver, a neck induction loop that emits the sound locally to the hearing aid, a battery charger, and various cables enabling connection to digital music devices.

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
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
07613389772555MEMINI E 5 6P R-R AI PH (sandalwood)050-1141-P3B12026-03-26
07613389772562MEMINI E 5 6P R-R AI PH (silver gray)050-1141-P6B12026-03-26
07613389772579MEMINI E 5 6P R-R AI PH (velvet black)050-1141-P8B12026-03-26
07613389772586MEMINI E 4 6P R-R AI PH (sand beige)050-1142-P1B12026-03-26
07613389772593MEMINI E 4 6P R-R AI PH (sandalwood)050-1142-P3B12026-03-26
07613389772609MEMINI E 4 6P R-R AI PH (silver gray)050-1142-P6B12026-03-26
07613389772616MEMINI E 4 6P R-R AI PH (velvet black)050-1142-P8B12026-03-26
07613389772623MEMINI E 3 6P R-R AI PH (sand beige)050-1143-P1B12026-03-26
07613389772630MEMINI E 3 6P R-R AI PH (sandalwood)050-1143-P3B12026-03-26
07613389772647MEMINI E 3 6P R-R AI PH (silver gray)050-1143-P6B12026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388201145STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201541STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201640AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201657AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201664AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201695NUEARStarkey Laboratories, Inc.ESD2025-06-25
00840388201701NUEARStarkey Laboratories, Inc.ESD2025-06-25
00840388201725MICROTECHStarkey Laboratories, Inc.ESD2025-06-25
00840388201732MICROTECHStarkey Laboratories, Inc.ESD2025-06-25
00840388201763AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201770AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201787AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201794AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201886AMPLIFONStarkey Laboratories, Inc.ESD2025-06-25
00840388201909AMPLIFONStarkey 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
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