DEPTHALON®

Basic Information

• Brand Name: DEPTHALON®
• Primary DI: 00650551097907
• Version / Model: 2102-04-091
• Catalog Number: 2102-04-091
• Company Name: PMT CORPORATION
• Labeler DUNS: 039576871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-26
• Public Version: 4
• Public Version Date: 2019-09-23
• Public Version Status: Update
• Public Device Record Key: ba6d99d2-8b2b-43a2-92fa-3c53a2b2b865

Device Description

sEEG, PLATINUM, 4 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZL	Electrode, Depth	Neurology	882.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00650551097907	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K151790	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Main Tube Length 27 Centimeter
Device Size Text, specify			Spacing 1.5 Millimeter
Device Size Text, specify			Recording Depth 12.5 Millimeter
Device Size Text, specify			Contact Length 2 Millimeter
Outer Diameter	0.8	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 58 – 78 Degrees Fahrenheit