DEVICE: GN Otometrics A/S (05713315004834)
Device Identifier (DI) Information
GN Otometrics A/S
REM/SPL Probe (Single)
In Commercial Distribution
Gn Otometrics A/S
REM/SPL Probe (Single)
In Commercial Distribution
Gn Otometrics A/S
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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36717 | Impedance audiometer |
An electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ETY | Tester, Auditory Impedance |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K033645 | 000 |
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
3cc34162-a055-45b3-8a24-1b81ca4fe8f0
December 03, 2020
4
September 23, 2016
December 03, 2020
4
September 23, 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
[?]
No Customer Contact currently defined