FDA.report

SIGNIA

Primary DI
05714880106367
Brand
SIGNIA
Company
Ws Audiology Usa, Inc.
Model
D&C Charger BTE SP
Catalog number
10991648
Device description
SET D&C CHARGER BTE SP (AZ)
Published
2024-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05714880106367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05714880106367057148801063675714880106367

GMDN Terms

TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Sterilization Methods

Method

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05714880290356hear.comHORIZON RIC 1 G8210523302026-01-12
05714880221558RextonReach iX-CIC Li 60210351952026-01-24
05714880221565RextonReach iX-CIC Li 60210351942026-01-24
05714880221572RextonReach iX-CIC Li 60210351962026-01-24
05714880221589RextonReach iX-CIC Li 60210351972026-01-24
05714880223477RextonReach iX-CIC Li 30210353062026-01-24
05714880223484RextonReach iX-CIC Li 30210353052026-01-24
05714880223491RextonReach iX-CIC Li 30210353072026-01-24
05714880223507RextonReach iX-CIC Li 30210353092026-01-24
05714880223712RextonReach iX-CIC Li 20210353182026-01-24
05714880223729RextonReach iX-CIC Li 20210353192026-01-24
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613389755763Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389755770Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389759112Phonak Audéo E90-Sphere Sonova AGOSM2026-03-17
07613389759129Phonak Audéo E70-Sphere Sonova AGOSM2026-03-17
07613389759136Phonak Audéo E50-Sphere Sonova AGOSM2026-03-17
07613389759150Phonak Audéo E-R Trial Sonova AGOSM2026-03-17
07613389759174Phonak Audéo ESphereTrial Sonova AGOSM2026-03-17
07613389761917Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761924Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761931Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761948Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761955Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761962Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761979Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761986Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761993Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389762006Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389762013Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762020Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762037Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762044Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762051Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762068Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762075Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762082Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762099Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762105Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762143Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762150Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762167Phonak Audéo E70-R Sonova AGOSM2026-03-17