DEVICE: NA (03664539000121)
Device Identifier (DI) Information
NA
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution
D08-15CT
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution
D08-15CT
DIXI MEDICAL
SEEG DEPTH ELECTRODE, 3x5 CONTACTS, EXPLORATION LENGTH 70MM, Ø 0.8MM, SHORT LENGTH
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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 [?] |
---|---|
K170959 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Special Insulating Length between groups of 5 contacts 11 Millimeters |
Device Size Text, specify: Contact Length 2 Millimeters |
Device Size Text, specify: Contact Spacing 3.5 Millimeters |
Device Record Status
11173e8c-94ad-402c-9d1c-a1ce2116583a
March 14, 2023
6
December 14, 2017
March 14, 2023
6
December 14, 2017
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+33381889890
info@diximedical.com
info@diximedical.com