DEVICE: microTargeting™ Array Electrode (00873263007907)

Device Identifier (DI) Information

microTargeting™ Array Electrode
22375Z-00790
In Commercial Distribution
22375Z
FHC, INC.
00873263007907
GS1

1
108179458 *Terms of Use
microTargeting™ Array Electrodes 5x Sterile
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
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
Depth electrode An electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GZL ELECTRODE, DEPTH
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K033173 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 268.5 Millimeter
Device Size Text, specify: Impedance: Megaohms
Outer Diameter: 0.55 Millimeter
Length: 3 Millimeter
Length: 276.5 Millimeter
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Device Record Status

97bd9ac5-572b-4008-a8f6-8d35565b9d76
September 23, 2019
2
August 24, 2019
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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
10873263007904 5 00873263007907 In Commercial Distribution PK/5
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Secondary DI

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

[?]
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
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)326-2905
fhcinc@fh-co.com
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