Unitron

Primary DI: 07630034331189
Brand: Unitron
Company: Unitron Hearing Ltd
Model: 063-5821-01
Catalog number: 063-5821-01
Device description: Stride 800 W 10A Dir
Published: 2016-09-12
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: MR Unsafe
Rx: false
OTC: false
Sterile: false
Single use: false

Related Records

Contact Domains

unitron.com

Product Codes

Code	Name
OSM	Hearing aid, air conduction with wireless technology

Product Code Classifications

Code	Device	Specialty	Class
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
07630034331189	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
07630034331189	07630034331189	7630034331189

GMDN Terms

Term	Definition
Canal air-conduction hearing aid	A 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.

Term

Definition

Canal air-conduction hearing aid

A 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

Contacts

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

Regulatory Flags

DUNS number: 201252087
Device count: 1
DM exempt: true
Premarket exempt: true
HCT/P: false
Kit: false
Combination product: false
Lot or batch: false
Serial number: true
Manufacturing date on label: true
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	Catalog	Published
07630034362732	UNITRON	063-6001-01	063-6001-01	2018-02-28
07630034362749	UNITRON	063-6002-01	063-6002-01	2018-02-28
07630034362756	UNITRON	063-6003-01	063-6003-01	2018-02-28
07630034362763	UNITRON	063-6004-01	063-6004-01	2018-02-28
07630034362770	UNITRON	063-6005-01	063-6005-01	2018-02-28
07630034362787	UNITRON	063-6006-01	063-6006-01	2018-02-28
07630034362794	UNITRON	063-6007-01	063-6007-01	2018-02-28
07630034362824	UNITRON	063-6008-01	063-6008-01	2018-02-28
07630034362831	UNITRON	063-6009-01	063-6009-01	2018-02-28
07630034362848	UNITRON	063-6010-01	063-6010-01	2018-02-28
07630034362855	UNITRON	063-6011-01	063-6011-01	2018-02-28
07630034362886	UNITRON	063-6012-01	063-6012-01	2018-02-28
07630034362893	UNITRON	063-6013-01	063-6013-01	2018-02-28
07630034362947	UNITRON	063-6014-01	063-6014-01	2018-02-28
07630034362961	UNITRON	063-6015-01	063-6015-01	2018-02-28
07630034362978	UNITRON	063-6016-01	063-6016-01	2018-02-28
07630034362985	UNITRON	063-6017-01	063-6017-01	2018-02-28
07630034362992	UNITRON	063-6018-01	063-6018-01	2018-02-28
07630034363005	UNITRON	063-6019-01	063-6019-01	2018-02-28
07630034363029	UNITRON	063-6020-01	063-6020-01	2018-02-28

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