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

• 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)