DEVICE: DEPTHALON® (00650551131496)

Device Identifier (DI) Information

DEPTHALON®
2102-16-154-NS
In Commercial Distribution
2102-16-154-NS
PMT CORPORATION
00650551131496
GS1

1
039576871 *Terms of Use
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 36MM SPACING BETWEEN CONTACTS #13 & #14
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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

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
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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: Main Tube Length 27 Centimeter
Device Size Text, specify: Spacing 3 Millimeter
Device Size Text, specify: Recording Depth 110 Millimeter
Device Size Text, specify: Contact Length 2 Millimeter
Outer Diameter: 0.8 Millimeter
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Device Record Status

ae491c6e-47c9-4a18-aacb-e10fc21f778a
September 23, 2019
2
November 06, 2018
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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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

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