DEVICE: DEPTHALON® (00650551098362)
Device Identifier (DI) Information
DEPTHALON®
2104-05-20-02-IL
In Commercial Distribution
2104-05-20-02-IL
PMT CORPORATION
2104-05-20-02-IL
In Commercial Distribution
2104-05-20-02-IL
PMT CORPORATION
MICROWIRE DEPTH ELECTRODE, 5 MACRO CONTACTS, 20 MICROWIRES, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GZL | Electrode, Depth |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 58 and 78 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Recording Depth 19.5 Millimeter |
Device Size Text, specify: Microwire Diameter 40 Micrometer |
Device Size Text, specify: Main Tube Length 16.5 Centimeter |
Device Size Text, specify: Contact Size 1.5 Millimeter |
Device Record Status
844f6262-4103-4119-be07-5a05a83f290e
September 23, 2019
3
January 28, 2018
September 23, 2019
3
January 28, 2018
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
[?]
800-626-5463
info@pmtcorp.com 800-626-5463
intl@pmtcorp.com
info@pmtcorp.com 800-626-5463
intl@pmtcorp.com