PlasmaJet Neutral Plasma Surgery System LS-CP 05-28H

GUDID M397LSCP0528H2

Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlasmaJet System

PLASMA SURGICAL, INC

Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece Plasma surgical system handpiece
Primary Device IDM397LSCP0528H2
NIH Device Record Key4cee1c81-427e-4c2c-8a34-592545276483
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasmaJet Neutral Plasma Surgery System
Version Model NumberLS-CP 05-28H
Catalog NumberLS-CP 05-28H
Company DUNS360799048
Company NamePLASMA SURGICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com
Phone1 678 578 4390
Emailcs@plasmasurgical.com

Device Dimensions

Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter
Length28 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM397LSCP0528H0 [Primary]
HIBCCM397LSCP0528H2 [Package]
Contains: M397LSCP0528H0
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-06-08
Device Publish Date2016-07-18

On-Brand Devices [PlasmaJet Neutral Plasma Surgery System]

M397SCDU280Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlamaJet System
M397SCDU120Single-Use Cut/Coagulation Handpiece for Open Surgery Handpiece for the PlasmaJet System
M397SCDU070Single-Use Cut/Coagulation Handpiece for Open Surgical for the PlasmaJet System
M397PS103130ZA0PlasmaJet Ultra Plus Console System (South Africa)
M397PS103130US0PlasmaJet Ultra Plus Console System (United State)
M397PS103130TR0PlasmaJet Ultra Plus Console System (Turkey)
M397PS103130SE0PlasmaJet Ultra Plus Console System (Sweden)
M397PS103130SA0PlasmaJet Ultra Plus Console System (Saudi Arabia)
M397PS103130RU0PlasmaJet Ultra Plus Console System (Russia)
M397PS103130RO0PlasmaJet Ultra Plus Console System (Romania)
M397PS103130PL0PlasmaJet Ultra Plus Console System (Poland)
M397PS103130NZ0PlasmaJet Ultra Plus Console System (New Zealand)
M397PS103130NO0PlasmaJet Ultra Plus Console System (Norway)
M397PS103130NL0PlasmaJet Ultra Plus Console System (Netherlands)
M397PS103130KW0PlasmaJet Ultra Plus Console System (Kuwait)
M397PS103130JP0PlasmaJet Ultra Plus Console System (Japan)
M397PS103130IT0PlasmaJet Ultra Plus Console System (Italy)
M397PS103130ISZA0PlasmaJet Ultra Plus Console System In-Service (South Africa)
M397PS103130ISUS0PlasmaJet Ultra Plus Console System In-Service (United State)
M397PS103130ISTR0PlasmaJet Ultra Plus Console System In-Service (Turkey)
M397PS103130ISSE0PlasmaJet Ultra Plus Console System In-Service (Sweden)
M397PS103130ISSA0PlasmaJet Ultra Plus Console System In-Service (Saudi Arabia)
M397PS103130ISRU0PlasmaJet Ultra Plus Console System In-Service (Russia)
M397PS103130ISRO0PlasmaJet Ultra Plus Console System In-Service (Romania)
M397PS103130ISPL0PlasmaJet Ultra Plus Console System In-Service (Poland)
M397PS103130ISNZ0PlasmaJet Ultra Plus Console System In-Service (New Zealand)
M397PS103130ISNO0PlasmaJet Ultra Plus Console System In-Service (Norway)
M397PS103130ISNL0PlasmaJet Ultra Plus Console System In-Service (Netherlands)
M397PS103130ISKW0PlasmaJet Ultra Plus Console System In-Service (Kuwait)
M397PS103130ISJP0PlasmaJet Ultra Plus Console System In-Service (Japan)
M397PS103130ISIT0PlasmaJet Ultra Plus Console System In-Service (Italy)
M397PS103130ISIS0PlasmaJet Ultra Plus Console System In-Service (Iceland)
M397PS103130ISIR0PlasmaJet Ultra Plus Console System In-Service (Iran)
M397PS103130ISIL0PlasmaJet Ultra Plus Console System In-Service (Isreal)
M397PS103130ISIE0PlasmaJet Ultra Plus Console System In-Service (Ireland)
M397PS103130ISHU0PlasmaJet Ultra Plus Console System In-Service (Hungary)
M397PS103130ISGB0PlasmaJet Ultra Plus Console System In-Service (Great Britain)
M397PS103130ISFR0PlasmaJet Ultra Plus Console System In-Service (France)
M397PS103130ISFI0PlasmaJet Ultra Plus Console System In-Service (Finland)
M397PS103130ISES0PlasmaJet Ultra Plus Console System In-Service (Spain)
M397PS103130ISDK0PlasmaJet Ultra Plus Console System In-Service (Denmark)
M397PS103130ISDE0PlasmaJet Ultra Plus Console System In-Service (Germany
M397PS103130ISCZ0PlasmaJet Ultra Plus Console System In-Service (Czech Republic)
M397PS103130ISCH0PlasmaJet Ultra Plus Console System In-Service (Switzerland)
M397PS103130ISCA0PlasmaJet Ultra Plus Console System In-Service (Canada)
M397PS103130ISBE0PlasmaJet Ultra Plus Console System In-Service (Belgium)
M397PS103130ISAU0PlasmaJet Ultra Plus Console System In-Service (Australia)
M397PS103130ISAT0PlasmaJet Ultra Plus Console System In-Service (Austria)
M397PS103130ISAE0PlasmaJet Ultra Plus Console System In-Service (United Arab Emirates)
M397PS103130IS0PlasmaJet Ultra Plus Console System (Iceland)
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