Rexton

Primary DI
04056839134306
Brand
Rexton
Company
Ws Audiology Usa, Inc.
Model
M-Core CROS IX-CIC
Catalog number
10990813
Device description
M-Core CROS IX-CIC Black Blue
Published
2023-09-13
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056839134306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056839134306040568391343064056839134306

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. 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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880295054SIGNIAActive Mini 7IX210540642026-05-22
05714880295061SIGNIAActive Mini 5IX210543622026-05-22
05714880295078SIGNIAActive Mini 5IX210543672026-05-22
05714880295689SIGNIAActive Mini 7IX210540692026-05-22
05714880295764SIGNIAActive Mini 3IX210543632026-05-22
05714880295771SIGNIAActive Mini 3IX210543682026-05-22
05714880295825SIGNIAActive Mini 2IX210543642026-05-22
05714880295832SIGNIAActive Mini 2IX210543692026-05-22
05714880295887SIGNIAActive Mini 1IX210543652026-05-22
05714880295894SIGNIAActive Mini 1IX210543702026-05-22
05714880295948SIGNIAActive Mini sDEMO DIX210543662026-05-22
05714880295955SIGNIAActive Mini sDEMO DIX210543712026-05-22
05714880295962SIGNIAKit Active Mini sDEMO DIX210543762026-05-22
05714880295979SIGNIAKit Active Mini 7IX210540742026-05-22
05714880296006SIGNIAKit Active Mini 5IX210543722026-05-22
05714880296037SIGNIAKit Active Mini 3IX210543732026-05-22
05714880296068SIGNIAKit Active Mini 2IX210543742026-05-22
05714880296099SIGNIAKit Active Mini 1IX210543752026-05-22
05714880290356hear.comHORIZON RIC 1 G8210523302026-01-12
05714880221558RextonReach iX-CIC Li 60210351952026-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880295054SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295061SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295078SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295689SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295764SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295771SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295825SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295832SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295887SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295894SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295948SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295955SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295962SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295979SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296006SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296037SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296068SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296099SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
07613389834147Phonak Audéo E90-Sphere Sonova AGKLW2026-03-17
07613389860498Phonak Audéo E30-Sphere Sonova AGKLW2026-03-17
07613389891171Phonak Audéo E90-RSonova AGKLW2026-03-16
05714464175529BernafonSbo Hearing A/SKLW2026-02-25
05714464175567NeutralSbo Hearing A/SKLW2026-02-25
05714464175598PhilipsSbo Hearing A/SKLW2026-02-25
05714464175628OticonSbo Hearing A/SKLW2026-02-25
05714464176151PhilipsSbo Hearing A/SKLW2026-02-25
05714464176168PhilipsSbo Hearing A/SKLW2026-02-25
05714464176335OticonSbo Hearing A/SKLW2026-02-25
05714464176359OticonSbo Hearing A/SKLW2026-02-25
05714464182848OticonSbo Hearing A/SKLW2026-02-25