DEPTHALON®

Basic Information

• Brand Name: DEPTHALON®
• Primary DI: 00650551068655
• Version / Model: 2102-04-023M2-NS
• Catalog Number: 2102-04-023M2-NS
• Company Name: PMT CORPORATION
• Labeler DUNS: 039576871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-03
• Public Version: 4
• Public Version Date: 2019-09-23
• Public Version Status: Update
• Public Device Record Key: 9556fcb6-38ef-44d2-8574-79ae2357ba04

Device Description

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR, MEG 2

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Hydrogen Peroxide

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	00650551068655	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 67 Centimeter
Device Size Text, specify			Contact Length 2 Millimeter
Device Size Text, specify			Recording Depth 17 Millimeter
Device Size Text, specify			Spacing 5 Millimeter

Storage Conditions

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