DEVICE: microTargeting™ Electrode (10873263007485)
Device Identifier (DI) Information
microTargeting™ Electrode
FC1003-00748
In Commercial Distribution
FC1003
FHC, INC.
FC1003-00748
In Commercial Distribution
FC1003
FHC, INC.
microTargeting Electrode 5x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GZL | ELECTRODE, DEPTH |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K033173 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 40 Degrees Celsius |
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity |
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 10 Millimeter |
Length: 276.5 Millimeter |
Length: 261.5 Millimeter |
Device Size Text, specify: Impedance: Megaohms |
Outer Diameter: 0.55 Millimeter |
Device Record Status
279d6099-9aff-4696-8771-7494370923d2
January 06, 2020
1
December 27, 2019
January 06, 2020
1
December 27, 2019
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00873263007488
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)326-2905
fhcinc@fh-co.com
fhcinc@fh-co.com