PlasmaJet Neutral Plasma Surgery System

Basic Information

• Brand Name: PlasmaJet Neutral Plasma Surgery System
• Primary DI: M397S2CDU7H0
• Version / Model: S2-CDU-7H
• Catalog Number: S2-CDU-7H
• Company Name: PLASMA SURGICAL, INC
• Labeler DUNS: 360799048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-07
• Public Version: 1
• Public Version Date: 2023-09-15
• Public Version Status: New
• Public Device Record Key: 05b612e6-0c42-4b2c-94a4-7f5a4a1eb75e

Device Description

Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System

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: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47275	Plasma surgical system handpiece	A hand-held instrument used with a plasma surgical system control unit to coagulate, cut, and/or vaporize/ablate tissue during open and/or laparoscopic surgery. Inert argon (Ar) gas is excited (ionized) in the instrument by a series of internal bipolar electrodes to generate plasma (atomic ions and free electrons) which emerges from the tip of the handpiece in a stream to release kinetic and thermal energy upon contact with tissue. Operation is regulated using a hand-control on the instrument or via a connected foot-switch. The instrument is typically in the form of a pen/pencil with attached cables for connection to the control unit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M397S2CDU7H0	HIBCC
Package	M397S2CDU7H2	HIBCC	Box	5	In Commercial Distribution
Package	M397S2CDU7H9	HIBCC	Box	15	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121977	000

Device Sizes

Type	Value	Unit	Text
Length	7	Centimeter