PMT® CORPORATION - SPHENOIDAL

Basic Information

• Brand Name: PMT® CORPORATION - SPHENOIDAL
• Primary DI: 00650551092902
• Version / Model: 2101-32-01-NS
• Catalog Number: 2101-32-01-NS
• Company Name: PMT CORPORATION
• Labeler DUNS: 039576871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-17
• Public Version: 4
• Public Version Date: 2019-09-23
• Public Version Status: Update
• Public Device Record Key: d7dd80df-66d3-4b9e-baa7-a3e146bc6ec2

Device Description

STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED

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
Package	10650551092909	GS1		2	In Commercial Distribution
Primary	00650551092902	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033730	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Recording Length 0.25 Inch
Needle Gauge	21	Gauge
Device Size Text, specify			Tip Size 3-5 Millimeter
Length	30	Centimeter
Device Size Text, specify			Wire Gauge 36 Gauge

Storage Conditions

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