DEVICE: PMT® CORPORATION - SPHENOIDAL (10650551092824)
Device Identifier (DI) Information
PMT® CORPORATION - SPHENOIDAL
2102-31-03
In Commercial Distribution
2102-31-03
PMT CORPORATION
2102-31-03
In Commercial Distribution
2102-31-03
PMT CORPORATION
PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
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 [?] |
---|---|
K033730 | 000 |
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: Wire Gauge 36 Gauge |
Length: 30 Centimeter |
Device Size Text, specify: Tip Size 3-5 Millimeter |
Needle Gauge: 21 Gauge |
Device Size Text, specify: Recording Length 0.25 Inch |
Device Record Status
719fa8da-6c07-4f32-a17c-f3a68b85d2c5
September 23, 2019
4
November 17, 2016
September 23, 2019
4
November 17, 2016
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:
00650551092827
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-626-5463
intl@pmtcorp.com 800-626-5463
info@pmtcorp.com
intl@pmtcorp.com 800-626-5463
info@pmtcorp.com