AccessGUDID - DEVICE: NA (03664539000039)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MICRODEEP DEPTH ELECTRODE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D08-08AM
Company Name: DIXI MEDICAL

Primary DI Number: 03664539000039
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 268009609 *Terms of Use

Device Description: SEEG DEPTH ELECTRODE, 8 CONTACTS, EXPLORATION LENGTH 26.5MM, Ø 0.8MM, LONG LENGTH

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
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 [?]
K170959	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Contact Spacing 3.5 Millimeters
Device Size Text, specify: Contact Length 2 Millimeters

Device Record Status

Public Device Record Key: ffec81ef-56d5-4140-961a-dc8d20016b86
Public Version Date: December 01, 2021
Public Version Number: 5
DI Record Publish Date: December 14, 2017