FDA.reportPublic FDA data

Phonak

Primary DI
07612904255566
Brand
Phonak
Company
Phonak AG
Model
052-3116-D02P5
Catalog number
052-3116-D02P5
Device description
Roger 15 (02) (champagne)
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
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
07612904255566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612904255566076129042555667612904255566

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
+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
07612847817678Phonak050-0905-G5050-0905-G52016-09-12
07612847818477Phonak050-0906-13050-0906-132016-09-12
07612847818484Phonak050-0906-33050-0906-332016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296429073GN HearingGn Hearing A/SESD2026-03-05
05708296429080GN HearingGn Hearing A/SESD2026-03-05
05708296429097GN HearingGn Hearing A/SESD2026-03-05
EDET030161medicalprint shell beige 2.0 1000gDETAX GmbHESD2026-02-25
00810068833218Lucid Hearing®HEARING LAB TECHNOLOGY, LLCESD2026-02-13
05708296382927BeltoneGn Hearing A/SESD2026-02-10
05708296382934BeltoneGn Hearing A/SESD2026-02-10
05708296382941BeltoneGn Hearing A/SESD2026-02-10
05708296383061BeltoneGn Hearing A/SESD2026-02-10
05708296383078BeltoneGn Hearing A/SESD2026-02-10
05708296383085BeltoneGn Hearing A/SESD2026-02-10
05708296383207BeltoneGn Hearing A/SESD2026-02-10
05708296383214BeltoneGn Hearing A/SESD2026-02-10
05708296383221BeltoneGn Hearing A/SESD2026-02-10
05708296383344BeltoneGn Hearing A/SESD2026-02-10
05708296383351BeltoneGn Hearing A/SESD2026-02-10
05708296383368BeltoneGn Hearing A/SESD2026-02-10
05708296383481GN ReSoundGn Hearing A/SESD2026-02-10
05708296383498GN ReSoundGn Hearing A/SESD2026-02-10
05708296383504GN ReSoundGn Hearing A/SESD2026-02-10
05708296383627GN ReSoundGn Hearing A/SESD2026-02-10
05708296383634GN ReSoundGn Hearing A/SESD2026-02-10
05708296383641GN ReSoundGn Hearing A/SESD2026-02-10
05708296383764GN ReSoundGn Hearing A/SESD2026-02-10
05708296383771GN ReSoundGn Hearing A/SESD2026-02-10
05708296383788GN ReSoundGn Hearing A/SESD2026-02-10
05708296383900GN ReSoundGn Hearing A/SESD2026-02-10
05708296383917GN ReSoundGn Hearing A/SESD2026-02-10
05708296383924GN ReSoundGn Hearing A/SESD2026-02-10
05708296384044GN HearingGn Hearing A/SESD2026-02-10