AccessGUDID - DEVICE: microTargeting™ Electrode (10873263001360)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ Electrode
Version or Model: FC1003-00136
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FC1003
Company Name: FHC, INC.

Primary DI Number: 10873263001360
Issuing Agency: GS1
Commercial Distribution End Date: January 10, 2023
Device Count: 6
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting Electrode 6x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam 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: 276.5 Millimeter
Length: 261.5 Millimeter
Device Size Text, specify: Impedance: Megaohms
Length: 10 Millimeter
Outer Diameter: 0.55 Millimeter

Device Record Status

Public Device Record Key: 3faefd94-6e85-43a3-a152-3102c437756b
Public Version Date: January 10, 2023
Public Version Number: 6
DI Record Publish Date: August 22, 2016