DEVICE: NA (04582275270020)

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Device Identifier (DI) Information

NA
EV-001

KONAN MEDICAL USA, INC.
04582275270020
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Vision electrophysiology analysis system An assembly of mains electricity (AC-powered) devices that provides visual stimuli (e.g., patterns of light, images) to a patient to measure, record, and display visual electrophysiologic responses [e.g., electroretinogram (ERG), visual evoked potential (VEP), and electrooculogram (EOG)], typically as an aid in the diagnosis and management of visual disorders involving ocular electrophysiology (EP), e.g., glaucoma. It may involve the use of electrodes placed on the patient's face and eyes, or the use of other devices such as visual stimulation goggles. The system may be used to screen infants and pre-school children for visual disorders without dilation or sedation.
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FDA Product Code

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Product Code Product Code Name
GWE Stimulator, photic, evoked response
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Sterilization

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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 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
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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