| Primary Device ID | M397PS103130HU0 |
| NIH Device Record Key | 8ede13be-16be-42b4-9589-89351c5b6c48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlasmaJet Neutral Plasma Surgery System |
| Version Model Number | PS10-3130-HU |
| Catalog Number | PS10-3130-HU |
| 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 |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com | |
| Phone | 6785784390 |
| cs@plasmasurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M397PS103130HU0 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-06-08 |
| Device Publish Date | 2018-10-02 |
| 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) |