AccessGUDID - DEVICE: microTargeting™ Electrode (10873263002565)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ Electrode
Version or Model: 44935Z-00256
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 44935Z
Company Name: FHC, INC.

Primary DI Number: 10873263002565
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(Z), Platform

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 [?]
Moist Heat or Steam Sterilization
Ethylene Oxide

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
Device Size Text, specify: Impedance: Megaohms
Length: 10 Millimeter
Outer Diameter: 0.55 Millimeter
Length: 220.72 Millimeter
Length: 205.72 Millimeter

Device Record Status

Public Device Record Key: cf58fd97-a0d0-4c5e-b44a-d57402ee605b
Public Version Date: September 23, 2019
Public Version Number: 4
DI Record Publish Date: September 17, 2016