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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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PlasmaJet Neutral Plasma Surgery System - M3970SCP0512H0

Single-use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CP 05-12H
In Commercial Distribution

  • M397OSCP0512H2 ()
  • M3970SCP0512H0 ()

  • Length: 12 Centimeter
OS-CP 05-12H

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397SCDU280

Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlamaJet System
PLASMA SURGICAL, INC
S-CDU+28
In Commercial Distribution

  • M397SCDU280 ()
  • M397SCDU282 ()

  • Length: 28 Centimeter
S-CDU-28

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397SCDU120

Single-Use Cut/Coagulation Handpiece for Open Surgery Handpiece for the PlasmaJet System
PLASMA SURGICAL, INC
S-CDU+12
In Commercial Distribution

  • M397SCDU120 ()
  • M397SCDU122 ()

  • Length: 12 Centimeter
S-CDU-12

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397SCDU070

Single-Use Cut/Coagulation Handpiece for Open Surgical for the PlasmaJet System
PLASMA SURGICAL, INC
S-CDU+07
In Commercial Distribution

  • M397SCDU070 ()
  • M397SCDU072 ()

  • Length: 7 Centimeter
S-CDU-07

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397LSCP05280

Single-Use Cut/Coagulation Handpiece for the Laparoscopic Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
LS-CP-05-28
In Commercial Distribution

  • M397LSCP05280 ()
  • M397LSCP05282 ()

  • Length: 28 Centimeter
LS-CP-05-28

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397LSCG05280

Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for PlamaJet System
PLASMA SURGICAL, INC
LS-CG-05-28
In Commercial Distribution

  • M397LSCG05280 ()
  • M397LSCG05282 ()

  • Length: 28 Centimeter
LS-CG-05-28

  • Plasma surgical system handpiece

Holster Option - M397HO280

Holster (Accessory) use for the Handpiece Holder
PLASMA SURGICAL, INC
HO-28
In Commercial Distribution

  • M397HO280 ()
  • M397HO282 ()

  • Length: 28 Centimeter
HO-28

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397GCDU280

Single-Use Cut/Coagulation Handpiece for Laparosopic Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
G-CDU+28
In Commercial Distribution

  • M397GCDU280 ()
  • M397GCDU282 ()

  • Length: 28 Centimeter
G-CDU-28

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397GCDU120

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
G-CDU+12
In Commercial Distribution

  • M397GCDU120 ()
  • M397GCDU122 ()

  • Length: 12 Centimeter
G-CDU-12

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397GCDU070

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
G-CDU+07
In Commercial Distribution

  • M397GCDU070 ()
  • M397GCDU072 ()

  • Length: 7 Centimeter
G-CDU-07

  • Plasma surgical system handpiece

IPS e.max Press - DIVO7166261

dental abutments
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
716626
In Commercial Distribution

  • DVIV7166260 ()
  • DIVO7166261 ()
  • DIVO7166262 ()
716626

  • Dental implant suprastructure, permanent, preformed

IPS e.max Press - DIVO7166251

dental abutments
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
716625
In Commercial Distribution

  • DVIV7166250 ()
  • DIVO7166251 ()
  • DIVO7166252 ()
716625

  • Dental implant suprastructure, permanent, preformed

IPS e.max Press - DIVO7166241

dental abutments
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
716624
In Commercial Distribution

  • DVIV7166240 ()
  • DIVO7166241 ()
  • DIVO7166242 ()
716624

  • Dental implant suprastructure, permanent, preformed

IPS e.max Press - DIVO7119811

dental abutments
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
711981
In Commercial Distribution

  • DVIV7119810 ()
  • DIVO7119811 ()
  • DIVO7119812 ()
711981

  • Dental implant suprastructure, permanent, preformed

Systemp.inlay Systemp.onlay - DVIV559586AN1

Systemp.inlay Refill 3x2,5 g Universal
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
559586AN
Not in Commercial Distribution

  • DVIV559586AN1 ()
  • DVIV559586AN0 ()
  • DVIV559586AN2 ()
559586AN

  • Dental composite resin

Heliosit - DVIV532629AN1

Heliosit Orthodontic Refill 3x2,5 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
532629AN
Not in Commercial Distribution

  • DVIV532629AN1 ()
  • DVIV532629AN0 ()
  • DVIV532629AN2 ()
532629AN

  • Orthodontic bracket adhesive

DRY320 - DRY320

A device to store and dry endoscopes
Wassenburg Medical, Inc.
DRY320
Not in Commercial Distribution

  • G434DRY320 ()
  • DRY320 ()


  • Endoscope drying/storage cabinet

ArcScan Insight 100 - B017ED102

No Description
ARCSCAN, INC.
EyeSeal Disposable
In Commercial Distribution

  • B017ED113 ()
  • B017ED102 ()
ED1

  • Ophthalmic ultrasound imaging system

Accuro - B015000010

No Description
RIVANNA MEDICAL, LLC
00001
In Commercial Distribution

  • B015000010 ()
  • B015000011 ()


  • Hand-held ultrasound imaging system, body-surface

OCS Liver System - B00944823

OCS Liver Perfusion Initiation Set
TRANSMEDICS, INC.
3400
In Commercial Distribution

  • B00944895 ()
  • B00944823 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
3400

  • Donor-organ preservation/transport perfusion initiation/termination set

OCS Liver System - B00944705

OCS Liver Perfusion Set
TRANSMEDICS, INC.
3200
In Commercial Distribution

  • B00944707 ()
  • B00944705 ()

  • Length: 27 Inch
  • Width: 27 Inch
  • Height: 21 Inch
3200

  • Liver donor-organ preservation/transport perfusion set

OCS Lung System - B00944670

OCS Lung Solution
TRANSMEDICS, INC.
2300
In Commercial Distribution

  • B00944671 ()
  • B00944670 ()

  • Height: 2.5 Inch
  • Width: 5.5 Inch
  • Length: 14 Inch
2300

  • Donor-organ/tissue/cell preservation solution

OCS Heart System - B00943661

Cable Tie Tool, Small Diameter
TRANSMEDICS, INC.
1461
In Commercial Distribution

  • B00943661 ()
  • B00943675 ()

  • Length: 12 Inch
  • Width: 9 Inch
  • Height: 2 Inch
1461

  • Donor-organ preservation/transport perfusion set vessel tie tool

OCS Lung System - B00943281

OCS Lung Perfusion Initiation Set
TRANSMEDICS, INC.
2402
In Commercial Distribution

  • B00943281 ()
  • B00937703 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2402

  • Donor-organ preservation/transport perfusion initiation/termination set

OCS Lung System - B00940001

OCS Lung Manual Inflation Set
TRANSMEDICS, INC.
2404
In Commercial Distribution

  • B00940013 ()
  • B00940001 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2404

  • Breathing circuit bag, single-use

Organ Care System - B00939270

OCS Wireless Monitor, Universal
TRANSMEDICS, INC.
2450
In Commercial Distribution

  • B00939301 ()
  • B00939270 ()

  • Height: 3.5 Inch
  • Width: 8.5 Inch
  • Length: 9.5 Inch
2450

  • Donor-organ preservation/transport system control unit

OCS Lung System - B00939251

OCS Lung Monitoring Gas Regulator Kit
TRANSMEDICS, INC.
2464
In Commercial Distribution

  • B00939313 ()
  • B00939251 ()

  • Height: 3 Inch
  • Width: 12 Inch
  • Length: 10 Inch
2464

  • Donor-organ preservation/transport system gas cylinder regulator

OCS Lung System - B00939240

OCS Lung Console
TRANSMEDICS, INC.
2000
In Commercial Distribution

  • B00939231 ()
  • B00939240 ()

  • Height: 29 Inch
  • Width: 28 Inch
  • Length: 17 Inch
2000

  • Lung donor-organ preservation/transport system

OCS Lung System - B00939180

OCS Lung Monitoring Gas Cylinder, Refill
TRANSMEDICS, INC.
2461
In Commercial Distribution

  • B00939183 ()
  • B00939180 ()

  • Height: 4 Inch
  • Width: 4 Inch
  • Length: 18 Inch
2461

  • Donor-organ preservation/transport system gas refillable cylinder

OCS Lung System - B00939170

OCS Lung Monitoring Gas Cylinder
TRANSMEDICS, INC.
2461
In Commercial Distribution

  • B00939173 ()
  • B00939170 ()

  • Height: 4 Inch
  • Width: 4 Inch
  • Length: 18 Inch
2461

  • Donor-organ preservation/transport system gas refillable cylinder

OCS Lung System - B00939111

OCS Lung Instrumentation Tool Set
TRANSMEDICS, INC.
2401
In Commercial Distribution

  • B00937673 ()
  • B00939111 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2401

  • Donor-organ preservation/transport perfusion set connection kit

OCS Lung System - B00938535

OCS Lung Perfusion Set
TRANSMEDICS, INC.
2200
In Commercial Distribution

  • B00938535 ()
  • B00938537 ()

  • Height: 21 Inch
  • Width: 27 Inch
  • Length: 27 Inch
2200

  • Lung donor-organ preservation/transport perfusion set

OCS Lung System - B00937641

OCS Lung Perfusion Termination Set
TRANSMEDICS, INC.
2403
In Commercial Distribution

  • B00937663 ()
  • B00937641 ()

  • Height: 4 Inch
  • Width: 12 Inch
  • Length: 18 Inch
2403

  • Donor-organ preservation/transport perfusion initiation/termination set

OCS Heart System - B00936463

OCS Cardioplegic Arrest Set
TRANSMEDICS, INC.
1421
In Commercial Distribution

  • B00936463 ()
  • B00936655 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
1421

  • Donor-organ preservation/transport perfusion initiation/termination set

OCS Heart System - B00936363

OCS Heart Instrumentation Tool Set
TRANSMEDICS, INC.
1401
In Commercial Distribution

  • B00936363 ()
  • B00936645 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
1401

  • Donor-organ preservation/transport perfusion set connection kit

OCS Lung System - B00928600

OCS Lung Preservation Gas Cylinder, Refill
TRANSMEDICS, INC.
2460
In Commercial Distribution

  • B00928603 ()
  • B00928600 ()

  • Height: 4 Inch
  • Width: 4 Inch
  • Length: 18 Inch
2460

  • Donor-organ preservation/transport system gas refillable cylinder

OCS Lung System - B00928590

OCS Lung Preservation Gas Cylinder
TRANSMEDICS, INC.
2460
In Commercial Distribution

  • B00928593 ()
  • B00928590 ()

  • Height: 4 Inch
  • Width: 4 Inch
  • Length: 18 Inch
2460

  • Donor-organ preservation/transport system gas refillable cylinder

OCS Heart System - B00925751

SvO2/HCT Probe
TRANSMEDICS, INC.
1427
In Commercial Distribution

  • B00925751 ()
  • B00925753 ()

  • Length: 9 Inch
  • Width: 5.13 Inch
  • Height: 2.3 Inch
1427

  • Extracorporeal blood parameter probe

OCS Heart System - B00925741

Coronary Flow Probe
TRANSMEDICS, INC.
1425
In Commercial Distribution

  • B00925741 ()
  • B00925743 ()

  • Length: 9 Inch
  • Width: 5.13 Inch
  • Height: 2.3 Inch
1425

  • Extracorporeal fluid flow probe

Organ Care System - B00925731

Pump Flow Probe
TRANSMEDICS, INC.
1426
In Commercial Distribution

  • B00925733 ()
  • B00925731 ()

  • Height: 2.3 Inch
  • Width: 5.13 Inch
  • Length: 9 Inch
1426

  • Extracorporeal fluid flow probe
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