DEVICE: DEPTHALON® (00650551040071)

Device Identifier (DI) Information

DEPTHALON®
2102-01-037
In Commercial Distribution
2102-01-037
PMT CORPORATION
00650551040071
GS1

1
039576871 *Terms of Use
DEPTH ELECTRODE, PLATINUM, TIP ONLY, INLINE CONNECTOR
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K151790 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 58 and 78 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Contact Length 2 Millimeter
Device Size Text, specify: Main Tube Length 36 Centimeter
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Device Record Status

a84f9999-66f6-40e5-ac13-495355d736f2
September 23, 2019
4
September 23, 2016
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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
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Secondary DI

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

[?]
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-626-5463
info@pmtcorp.com
800-626-5463
intl@pmtcorp.com
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