DEVICE: microTargeting™ Electrode (10873263007959)

Device Identifier (DI) Information

microTargeting™ Electrode
35325Z-00795
In Commercial Distribution
35325Z
FHC, INC.
10873263007959
GS1

6
108179458 *Terms of Use
microTargeting™ Single Frame Platinum 6x Non Sterile
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GZL ELECTRODE, DEPTH
CLOSE

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
CLOSE

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
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 0.86 Millimeter
Length: 271.4 Millimeter
Length: 263.4 Millimeter
Length: 3 Millimeter
Device Size Text, specify: Impedance: Megaohms
CLOSE

Device Record Status

a905c69a-06b9-4b41-891c-cca7ebe7263c
September 23, 2019
2
August 24, 2019
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00873263007952 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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