FDA.report

DEPTHALON®

Primary DI
00650551005223
Brand
DEPTHALON®
Company
PMT CORPORATION
Model
2102-04-004
Device description
DEPTH, PLATINUM, 4 CONTACT, IOM CONNECTOR, REMOVABLE STYLET, 1.3MM OD, 5MM CONTACT LENGTH, 35MM RECORDING LENGTH, 10MM CTC SPACING, 213CM MAIN TUBE LENGTH
Published
2025-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GZLElectrode, Depth

Product Code Classifications

CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00650551005223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551005223006505510052236505510052230650551005223

GMDN Terms

TermDefinition
Depth electrodeAn 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
039576871
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00650551002154INTEGRA®3611-204-2I-ST2025-03-19
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00650551002772INTEGRA®3610-76-2I-ST2025-03-19
00650551002833INTEGRA®3612-06R-IR-ST2025-03-19
00650551002932ALLURA®3321-214-T2025-03-19
00650551002963INTEGRA®3612-61A-IR-ST72025-03-19
00650551003083INTEGRA®3610-23-32025-03-19
00650551003090INTEGRA®3611-674-32025-03-19
00650551003168INTEGRA®3611ES-12-IR-ST2025-03-19
00650551003175INTEGRA®3611ES-13-IR-ST2025-03-19
00650551003182INTEGRA®3612ES-04R-IR-ST2025-03-19
00650551003205INTEGRA®3610-579-22025-03-19
00650551003212INTEGRA®3611-675-22025-03-19

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