FDA.reportPublic FDA data

Phonak Brand

Primary DI
07613389359916
Brand
Phonak Brand
Company
Sonova AG
Model
050-0815-P4
Catalog number
050-0815-P4
Device description
Naida Naída P30-UP (chestnut)
Published
2020-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
07613389359916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389359916076133893599167613389359916

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA 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
+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
07613389755763Phonak Audéo E50-R(sand beige)050-1136-P12026-03-17
07613389755770Phonak Audéo E30-R(sand beige)050-1137-P12026-03-17
07613389759112Phonak Audéo E90-Sphere (sand beige)050-1141-P12026-03-17
07613389759129Phonak Audéo E70-Sphere (sand beige)050-1142-P12026-03-17
07613389759136Phonak Audéo E50-Sphere (sand beige)050-1143-P12026-03-17
07613389759150Phonak Audéo E-R Trial (silver gray)050-1145-P62026-03-17
07613389759174Phonak Audéo ESphereTrial (silver gray)050-1147-P62026-03-17
07613389761917Phonak Audéo E30-R(sandalwood)050-1137-P32026-03-17
07613389761924Phonak Audéo E30-R(chestnut)050-1137-P42026-03-17
07613389761931Phonak Audéo E30-R(champagne)050-1137-P52026-03-17
07613389761948Phonak Audéo E30-R(silver gray)050-1137-P62026-03-17
07613389761955Phonak Audéo E30-R(graphite gray)050-1137-P72026-03-17
07613389761962Phonak Audéo E30-R(velvet black)050-1137-P82026-03-17
07613389761979Phonak Audéo E30-R(Copper)050-1137-1A2026-03-17
07613389761986Phonak Audéo E30-R(sienna red)050-1137-8A2026-03-17
07613389761993Phonak Audéo E30-R(atlantic green)050-1137-9A2026-03-17
07613389762006Phonak Audéo E30-R(beige)050-1137-H02026-03-17
07613389762013Phonak Audéo E50-R(sandalwood)050-1136-P32026-03-17
07613389762020Phonak Audéo E50-R(chestnut)050-1136-P42026-03-17
07613389762037Phonak Audéo E50-R(champagne)050-1136-P52026-03-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05714880292152WidexWidex A/SOSM2026-05-22
05714880292169WidexWidex A/SOSM2026-05-22
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05714880292183WidexWidex A/SOSM2026-05-22
05714880292190WidexWidex A/SOSM2026-05-22
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05714880292237WidexWidex A/SOSM2026-05-22
05714880292244WidexWidex A/SOSM2026-05-22
05714880292251WidexWidex A/SOSM2026-05-22
05714880292268WidexWidex A/SOSM2026-05-22
05714880292275WidexWidex A/SOSM2026-05-22
05714880292282WidexWidex A/SOSM2026-05-22
05714880292299WidexWidex A/SOSM2026-05-22
05714880292305WidexWidex A/SOSM2026-05-22
05714880292312WidexWidex A/SOSM2026-05-22
05714880292329WidexWidex A/SOSM2026-05-22
05714880292336WidexWidex A/SOSM2026-05-22
05714880292343WidexWidex A/SOSM2026-05-22
05714880292350WidexWidex A/SOSM2026-05-22
05714880292367WidexWidex A/SOSM2026-05-22