DEVICE: NA (04582275270037)

Device Identifier (DI) Information

NA
M339 DME CARBON CL
In Commercial Distribution

KONAN MEDICAL USA, INC.
04582275270037
GS1

1
788439219 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Visual evoked-potential electrode An electrical conductor intended to be placed on the skin to record changes in the electrical potential for the purpose of measuring visual evoked responses. It is typically placed on the forehead of the patient at strategic points around the eyes. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
GXY ELECTRODE, CUTANEOUS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
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

d679f809-ee0b-4afe-85e8-0092f303b7eb
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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