FDA.report

Phonak Brand

Primary DI
07613389501506
Brand
Phonak Brand
Company
Sonova AG
Model
050-1013-H0
Device description
Phonak CROS L-R (beige)
Published
2022-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

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
07613389501506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613389501506076133895015067613389501506

GMDN Terms

TermDefinition
Contralateral hearing unitA passive (i.e., non-powered) acoustic device intended to compensate for total hearing loss in one ear, by transmitting sound received by a microphone from the deaf ear to an active (i.e., powered) hearing aid worn on the hearing ear. This contralateral routing of sound (CROS) technology is designed to improve awareness of sounds (e.g., traffic, speech) emanating from all directions. The device typically consists of a microphone contained in a case worn behind-the-ear (BTE) with a connection cable. The cable both transmits the power from, and the signal to, the active hearing aid.

Sterilization Methods

Method

Regulatory Flags

DUNS number
480662550
Device count
1
DM exempt
false
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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