DEVICE: Siemens (04047622006481)
Device Identifier (DI) Information
Siemens
HA CARAT 3BX GNT
In Commercial Distribution
10828764
SIVANTOS, INC.
HA CARAT 3BX GNT
In Commercial Distribution
10828764
SIVANTOS, INC.
Siemens HA CARAT 3BX GNT Hearing Aid
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Behind-the-ear 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 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. |
FDA Product Code
[?]Product Code | Product Code Name |
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OSM | Hearing Aid, Air Conduction With Wireless Technology |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b43e7dfc-eca0-44e5-8f8c-c3419cb50781
March 29, 2018
2
May 03, 2016
March 29, 2018
2
May 03, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
17325626600
consumerrelations@sivantos.com
consumerrelations@sivantos.com