DEVICE: DEPTHALON (00650551001386)

Device Identifier (DI) Information

DEPTHALON
2102-16-178
In Commercial Distribution

PMT CORPORATION
00650551001386
GS1

1
039576871 *Terms of Use
SEEG, 16 CONTACT, 6-2MM & 10-0.5MM CONTACT, NON-STANDARD SPACING AND 27MM BETWEEN CONTACT 9&10 WITH 6-2MM BLANK CONTACTS, 60MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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
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FDA Product Code

[?]
Product Code Product Code Name
GZL Electrode, Depth
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

84446e96-240e-467c-9c28-92e6124f5504
July 07, 2021
1
June 29, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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