FDA.report

Phonak

Primary DI
07613275537602
Brand
Phonak
Company
Sonova AG
Model
050-0277-P3
Catalog number
050-0277-P3
Device description
Phonak Audeo B50-Direct (sandalwood)
Published
2017-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613275537602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613275537602076132755376027613275537602

GMDN Terms

TermDefinition
Receiver-in-canal 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 consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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. 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

Contacts

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 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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