DEVICE: 2mm Cueva Electrode Kit (00841823100856)
Device Identifier (DI) Information
2mm Cueva Electrode Kit
CNE1-2KDINX
In Commercial Distribution
CNE1-2KDINX
Ad-Tech Medical Instrument Corporation
CNE1-2KDINX
In Commercial Distribution
CNE1-2KDINX
Ad-Tech Medical Instrument Corporation
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
No | |
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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 |
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GZL | ELECTRODE, DEPTH |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K944061 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: To be stored and used within typical hospital/office room ambient temperature and humidity conditions |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
867b8e9d-295e-49ec-9177-b1097acec892
August 23, 2023
5
September 23, 2016
August 23, 2023
5
September 23, 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 |
---|---|---|---|---|---|
90841823100859 | 2 | 00841823100856 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+1(800)776-1555
sales@adtechmedical.com
sales@adtechmedical.com