PlasmaJet Neutral Plasma Surgery System PS10-3130IS-US

GUDID M397PS103130ISUS0

PlasmaJet Ultra Plus Console System In-Service (United State)

PLASMA SURGICAL, INC

Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system Plasma surgical system

• Primary Device ID: M397PS103130ISUS0
• NIH Device Record Key: 27038e7c-6dcb-401d-824d-ac60882d56aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlasmaJet Neutral Plasma Surgery System
• Version Model Number: PS10-3130IS-US
• Catalog Number: PS10-3130IS-US
• Company DUNS: 360799048
• Company Name: PLASMA SURGICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M397PS103130ISUS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121977

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-08
• Device Publish Date: 2018-10-02

On-Brand Devices [PlasmaJet Neutral Plasma Surgery System]

• M397SCDU280: Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlamaJet System
• M397SCDU120: Single-Use Cut/Coagulation Handpiece for Open Surgery Handpiece for the PlasmaJet System
• M397SCDU070: Single-Use Cut/Coagulation Handpiece for Open Surgical for the PlasmaJet System
• M397PS103130ZA0: PlasmaJet Ultra Plus Console System (South Africa)
• M397PS103130US0: PlasmaJet Ultra Plus Console System (United State)
• M397PS103130TR0: PlasmaJet Ultra Plus Console System (Turkey)
• M397PS103130SE0: PlasmaJet Ultra Plus Console System (Sweden)
• M397PS103130SA0: PlasmaJet Ultra Plus Console System (Saudi Arabia)
• M397PS103130RU0: PlasmaJet Ultra Plus Console System (Russia)
• M397PS103130RO0: PlasmaJet Ultra Plus Console System (Romania)
• M397PS103130PL0: PlasmaJet Ultra Plus Console System (Poland)
• M397PS103130NZ0: PlasmaJet Ultra Plus Console System (New Zealand)
• M397PS103130NO0: PlasmaJet Ultra Plus Console System (Norway)
• M397PS103130NL0: PlasmaJet Ultra Plus Console System (Netherlands)
• M397PS103130KW0: PlasmaJet Ultra Plus Console System (Kuwait)
• M397PS103130JP0: PlasmaJet Ultra Plus Console System (Japan)
• M397PS103130IT0: PlasmaJet Ultra Plus Console System (Italy)
• M397PS103130ISZA0: PlasmaJet Ultra Plus Console System In-Service (South Africa)
• M397PS103130ISUS0: PlasmaJet Ultra Plus Console System In-Service (United State)
• M397PS103130ISTR0: PlasmaJet Ultra Plus Console System In-Service (Turkey)
• M397PS103130ISSE0: PlasmaJet Ultra Plus Console System In-Service (Sweden)
• M397PS103130ISSA0: PlasmaJet Ultra Plus Console System In-Service (Saudi Arabia)
• M397PS103130ISRU0: PlasmaJet Ultra Plus Console System In-Service (Russia)
• M397PS103130ISRO0: PlasmaJet Ultra Plus Console System In-Service (Romania)
• M397PS103130ISPL0: PlasmaJet Ultra Plus Console System In-Service (Poland)
• M397PS103130ISNZ0: PlasmaJet Ultra Plus Console System In-Service (New Zealand)
• M397PS103130ISNO0: PlasmaJet Ultra Plus Console System In-Service (Norway)
• M397PS103130ISNL0: PlasmaJet Ultra Plus Console System In-Service (Netherlands)
• M397PS103130ISKW0: PlasmaJet Ultra Plus Console System In-Service (Kuwait)
• M397PS103130ISJP0: PlasmaJet Ultra Plus Console System In-Service (Japan)
• M397PS103130ISIT0: PlasmaJet Ultra Plus Console System In-Service (Italy)
• M397PS103130ISIS0: PlasmaJet Ultra Plus Console System In-Service (Iceland)
• M397PS103130ISIR0: PlasmaJet Ultra Plus Console System In-Service (Iran)
• M397PS103130ISIL0: PlasmaJet Ultra Plus Console System In-Service (Isreal)
• M397PS103130ISIE0: PlasmaJet Ultra Plus Console System In-Service (Ireland)
• M397PS103130ISHU0: PlasmaJet Ultra Plus Console System In-Service (Hungary)
• M397PS103130ISGB0: PlasmaJet Ultra Plus Console System In-Service (Great Britain)
• M397PS103130ISFR0: PlasmaJet Ultra Plus Console System In-Service (France)
• M397PS103130ISFI0: PlasmaJet Ultra Plus Console System In-Service (Finland)
• M397PS103130ISES0: PlasmaJet Ultra Plus Console System In-Service (Spain)
• M397PS103130ISDK0: PlasmaJet Ultra Plus Console System In-Service (Denmark)
• M397PS103130ISDE0: PlasmaJet Ultra Plus Console System In-Service (Germany
• M397PS103130ISCZ0: PlasmaJet Ultra Plus Console System In-Service (Czech Republic)
• M397PS103130ISCH0: PlasmaJet Ultra Plus Console System In-Service (Switzerland)
• M397PS103130ISCA0: PlasmaJet Ultra Plus Console System In-Service (Canada)
• M397PS103130ISBE0: PlasmaJet Ultra Plus Console System In-Service (Belgium)
• M397PS103130ISAU0: PlasmaJet Ultra Plus Console System In-Service (Australia)
• M397PS103130ISAT0: PlasmaJet Ultra Plus Console System In-Service (Austria)
• M397PS103130ISAE0: PlasmaJet Ultra Plus Console System In-Service (United Arab Emirates)
• M397PS103130IS0: PlasmaJet Ultra Plus Console System (Iceland)