FDA.reportPublic FDA data

Rexton

Primary DI
05714880156720
Brand
Rexton
Company
Ws Audiology Usa, Inc.
Model
BiCore CROS R312 Demo
Catalog number
21002396
Device description
BiCore CROS R312 Demo Granite
Published
2023-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air Conduction
KLWMasker, Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714880156720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880156720057148801567205714880156720

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880113778CONNEXXSmart Key109398752026-05-28
05714880214345Audio ServiceR Li T 8.8210250432026-05-28
05714880214369Audio ServiceR Li T 8.8210250412026-05-28
05714880214376Audio ServiceR Li T 8.8210250402026-05-28
05714880214383Audio ServiceR Li T 8.8210250392026-05-28
05714880214390Audio ServiceR Li T 8.8210250382026-05-28
05714880214413Audio ServiceR Li T 8.8210250362026-05-28
05714880214420Audio ServiceR Li T 8.8210250352026-05-28
05714880214543Audio ServiceR Li T 8.16210250232026-05-28
05714880214567Audio ServiceR Li T 8.16210250212026-05-28
05714880214574Audio ServiceR Li T 8.16210250202026-05-28
05714880214581Audio ServiceR Li T 8.16210250192026-05-28
05714880214598Audio ServiceR Li T 8.16210250182026-05-28
05714880214611Audio ServiceR Li T 8.16210250162026-05-28
05714880214628Audio ServiceR Li T 8.16210250152026-05-28
05714880219425Audio ServiceIF CIC Li 8.16210349062026-05-28
05714880219432Audio ServiceIF CIC Li 8.16210349072026-05-28
05714880219449Audio ServiceIF CIC Li 8.16210349122026-05-28
05714880219456Audio ServiceIF CIC Li 8.16210349132026-05-28
05714880219463Audio ServiceIF CIC Li 8.16210349142026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880214345Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214611Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214628Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219425Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219432Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219449Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219456Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219463Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219470Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219869Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219876Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219883Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219890Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219906Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219913Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219944Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219951Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
EPRCA0032900otosil ES-1.1 pro3dure medical GmbHESD2022-09-15
00858177007823PersonaINTRICON CORPORATIONESD2022-06-21