FDA.report

Signia

Primary DI
04063006013302
Brand
Signia
Company
Ws Audiology Usa, Inc.
Model
Pure Charge&Go 2X
Catalog number
10986272
Device description
Pure Charge&Go 2X Pearl White
Published
2023-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KLWMasker, Tinnitus

Product Code Classifications

CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04063006013302PrimaryGS10

GMDN Terms

TermDefinition
Air-conduction hearing aid, receiver-in-canalA 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
17325626600consumerrelations@sivantos.com

Regulatory Flags

DUNS number
157412271
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05714880223736RextonReach iX-CIC Li 20210353202026-01-24
05714880223743RextonReach iX-CIC Li 20210353212026-01-24
05714880275407RextonReach CROS R-Li T BC210473582026-01-24
05714880275438RextonReach CROS R-Li T BC210473552026-01-24
05714880275445RextonReach CROS R-Li T BC210473542026-01-24
05714880275469RextonReach CROS R-Li T BC210473522026-01-24
05714880289640TRUHEARINGTH Advanced 7 SP BTE LI210525382026-01-23
05714880289657TRUHEARINGTH Premium 7 SP BTE LI210525372026-01-23
05714880289664TRUHEARINGTH Advanced 7 SP BTE LI210525362026-01-23

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05714464176168PhilipsSbo Hearing A/SKLW2026-02-25
05714464176335OticonSbo Hearing A/SKLW2026-02-25
05714464176359OticonSbo Hearing A/SKLW2026-02-25
05714464182848OticonSbo Hearing A/SKLW2026-02-25
05714464182855OticonSbo Hearing A/SKLW2026-02-25
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05714464182893OticonSbo Hearing A/SKLW2026-02-25
05714464182916OticonSbo Hearing A/SKLW2026-02-25
05714464182985OticonSbo Hearing A/SKLW2026-02-25
05714464183005OticonSbo Hearing A/SKLW2026-02-25
05714464183050OticonSbo Hearing A/SKLW2026-02-25
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05714464183227OticonSbo Hearing A/SKLW2026-02-25
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05714464183241OticonSbo Hearing A/SKLW2026-02-25