FDA.reportPublic FDA data

REXTON

Primary DI
05714880299694
Brand
REXTON
Company
Ws Audiology Usa, Inc.
Model
Reach IF ITC-Li BT SDemo
Catalog number
21056477
Device description
S_ITE REACHIFITC-LIBTSDEMOR GNBLK
Published
2026-10-28
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
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714880299694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880299694057148802996945714880299694

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, canalA 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 miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
DM exempt
false
Premarket exempt
false
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
05714880299359AudioServiceIF ITC Li 8.12210564072026-10-28
05714880299403AudioServiceIF ITC Li 8.12210564202026-10-28
05714880299410AudioServiceIF ITC Li 8.12210564192026-10-28
05714880299427AudioServiceIF ITC Li 8.12210564082026-10-28
05714880299564REXTONReach IF ITC-Li BT 80210564602026-10-28
05714880299571REXTONReach IF ITC-Li BT 80210564622026-10-28
05714880299588REXTONReach IF ITC-Li BT 80210564632026-10-28
05714880299595REXTONReach IF ITC-Li BT 80210564652026-10-28
05714880299601REXTONReach IF ITC-Li BT 60210564682026-10-28
05714880299618REXTONReach IF ITC-Li BT 60210564692026-10-28
05714880299625REXTONReach IF ITC-Li BT 60210564702026-10-28
05714880299632REXTONReach IF ITC-Li BT 60210564712026-10-28
05714880299649REXTONReach IF ITC-Li BT 40210564722026-10-28
05714880299656REXTONReach IF ITC-Li BT 40210564732026-10-28
05714880299663REXTONReach IF ITC-Li BT 40210564742026-10-28
05714880299670REXTONReach IF ITC-Li BT 40210564752026-10-28
05714880299687REXTONReach IF ITC-Li BT SDemo210564762026-10-28
05714880299991MIRACLE EARMEMINI I 5 5w ITC-R STD210565402026-10-27
05714880300000MIRACLE EARMEMINI I 5 5w ITC-R STD210565412026-10-27
05714880300017MIRACLE EARMEMINI I 5 5w ITC-R STD210565462026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880299359AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299359AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299403AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299403AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299410AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299410AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299427AudioServiceWs Audiology Usa, Inc.KLW2026-10-28
05714880299427AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299564REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299564REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299571REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299571REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299588REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299588REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299595REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299595REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299601REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299601REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299618REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299618REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299625REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299625REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299632REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299632REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299649REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299649REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299656REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299656REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299663REXTONWs Audiology Usa, Inc.KLW2026-10-28
05714880299663REXTONWs Audiology Usa, Inc.OSM2026-10-28