FDA.reportPublic FDA data

UNITRON

Primary DI
07630034362732
Brand
UNITRON
Company
Unitron Hearing Ltd
Model
063-6001-01
Catalog number
063-6001-01
Device description
T Insera 500 10A Omni
Published
2018-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
07630034362732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630034362732076300343627327630034362732

GMDN Terms#

Term, Definition table
TermDefinition
Canal air-conduction hearing aidA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 519 895 0100Quality@unitron.com

Regulatory Flags#

DUNS number
201252087
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00698764593694Unitron076-5037-T820076-5037-T8202016-09-12
00698764424127Unitron076-5016-M520076-5016-M5202016-09-12
00698764424769Unitron076-5014-00001076-5014-000012016-09-12
00698764479707Unitron050-5600-P6050-5600-P62016-09-12
07630034300000Unitron050-5695-P7050-5695-P72016-09-12
07630034300017Unitron050-5695-P6050-5695-P62016-09-12
07630034300024Unitron050-5694-S7050-5694-S72016-09-12
07630034300031Unitron050-5694-S6050-5694-S62016-09-12
07630034300048Unitron050-5694-S5050-5694-S52016-09-12
07630034300055Unitron050-5694-S3050-5694-S32016-09-12
07630034300062Unitron050-5694-S2050-5694-S22016-09-12
07630034300079Unitron050-5694-Q9050-5694-Q92016-09-12
07630034300086Unitron050-5694-P8050-5694-P82016-09-12
07630034300093Unitron050-5694-P7050-5694-P72016-09-12
07630034300109Unitron050-5694-P6050-5694-P62016-09-12
07630034300116Unitron050-5694-P4050-5694-P42016-09-12
07630034300123Unitron050-5694-P2050-5694-P22016-09-12
07630034300130Unitron050-5694-01050-5694-012016-09-12
07630034300147Unitron050-5693-S7050-5693-S72016-09-12
07630034300154Unitron050-5693-S6050-5693-S62016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05714880295795SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
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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