DEVICE: GN Otometrics A/S (05713315005268)

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Device Identifier (DI) Information

GN Otometrics A/S
1085, GOGGLE HOME KIT

Gn Otometrics A/S
05713315005268
GS1
1
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
Electronystagmograph A graphic recorder used for detecting the electrical potential caused by eye movements. This recorder includes an electrode for each eye and one on the forehead (multichannel recording) for measuring the potential from both eyes simultaneously, or repositioning of the electrodes before each test for single channel recording. Electronystagmographs are used for detecting multiple sclerosis, vestibular dysfunctions, the presence of drugs and other specific disorders characterized by involuntary eye movement (nystagmus).
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FDA Product Code

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Product Code Product Code Name
GWN Nystagmograph
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Sterilization

No
No
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 Status

In Commercial Distribution
September 23, 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
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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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