DEVICE: GN Otometrics A/S (05713315001901)

Device Identifier (DI) Information

GN Otometrics A/S
"Immittance Prove Wax Filter Kit
In Commercial Distribution

Gn Otometrics A/S
05713315001901
GS1

1
306633756 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
ETY Tester, Auditory Impedance
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K033645 000
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0eec1d55-1a7f-4009-b464-67b0ac46d4e5
July 06, 2018
3
September 17, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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Customer Contact

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No Customer Contact currently defined
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