DEVICE: microTargeting™ Electrode (00873263004920)

Device Identifier (DI) Information

microTargeting™ Electrode
MTSWLP(JN)(JN1)-00492
In Commercial Distribution
MTSWLP(JN)(JN1)
FHC, INC.
00873263004920
GS1

1
108179458 *Terms of Use
microTargeting(TM) Electrode, shielded, tungsten, DZAP(L), sterile
CLOSE

Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
32556 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.
Active false
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
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Impedance: Megaohms
Length: 251.4 Millimeter
Length: 278.4 Millimeter
Length: 25 Millimeter
Outer Diameter: 0.77 Millimeter
CLOSE

Device Record Status

12a2d462-2ee6-4e98-b2e7-089fc84d6963
September 23, 2019
4
September 17, 2016
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
10873263004927 5 00873263004920 In Commercial Distribution PK/5
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found 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