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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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Disposable Accessories Kit - 00850470007036

No Description
RESTORATION ROBOTICS, INC.
18G
In Commercial Distribution

  • 00850470007036 ()
FP-45173

  • Hair extraction punch

ARTAS System - 00850470007029

No Description
RESTORATION ROBOTICS, INC.
Accessories Kit
In Commercial Distribution

  • 00850470007029 ()
FP-26000

  • Robotic surgical arm system

ARTAS System - 00850470007012

No Description
RESTORATION ROBOTICS, INC.
Chair
In Commercial Distribution

  • 00850470007012 ()
ASY-45179

  • Robotic surgical arm system

Innocor - 05713867000100

Innocor Cardio-pulmonary function test equipment
Innovision ApS
INN00010-1
In Commercial Distribution

  • 05713867000100 ()


  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
  • Cardiopulmonary stress exercise monitoring system

Innocor - 05713867000001

Innocor Cardio-pulmonary function test equipment
Innovision ApS
INN00010
In Commercial Distribution

  • 05713867000001 ()


  • Cardiopulmonary stress exercise monitoring system
  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult

Senhance - 00815440020811

Bipolar Maryland Dissector
Asensus Surgical, Inc.
X0005149
In Commercial Distribution

  • 00815440020811 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
220-11019

  • Robotic electrosurgical instrument, bipolar, reusable

Senhance - 00815440020804

Bipolar Curved Scissors
Asensus Surgical, Inc.
X0005148
In Commercial Distribution

  • 00815440020804 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
220-11021

  • Robotic electrosurgical instrument, bipolar, reusable

Senhance - 00815440020781

Bipolar Large Grasping Forceps
Asensus Surgical, Inc.
X0005146
In Commercial Distribution

  • 00815440020781 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
220-11017

  • Robotic electrosurgical instrument, bipolar, reusable

Senhance - 00815440020712

Needle Holder Straight
Asensus Surgical, Inc.
X0007218
In Commercial Distribution

  • 00815440020712 ()

  • Length: 280 Millimeter
  • Outer Diameter: 3 Millimeter
200-11016

  • Robotic surgical forceps, reusable

Senhance - 00815440020545

Adapter, Monopolar L-Hook Electrode, Long
Asensus Surgical, Inc.
X9007036
In Commercial Distribution

  • 00815440020545 ()
210-21038

  • Robotic surgical arm system

Senhance - 00815440020521

Adapter, Monopolar Maryland Dissector, Long
Asensus Surgical, Inc.
X9007033
In Commercial Distribution

  • 00815440020521 ()
210-21036

  • Robotic surgical arm system

Senhance - 00815440020507

Adapter, Monopolar Curved Metzenbaum Scissors, Long
Asensus Surgical, Inc.
X9007027
In Commercial Distribution

  • 00815440020507 ()
210-21032

  • Robotic surgical arm system

Senhance - 00815440020484

Adapter, Needle Holder Left, Long
Asensus Surgical, Inc.
X9007024
In Commercial Distribution

  • 00815440020484 ()
200-21064

  • Robotic surgical arm system

Senhance - 00815440020460

Adapter, Needle Holder Right, Long
Asensus Surgical, Inc.
X9007021
In Commercial Distribution

  • 00815440020460 ()
200-21062

  • Robotic surgical arm system

Senhance - 00815440020453

Adapter, Needle Holder Right
Asensus Surgical, Inc.
X9007020
In Commercial Distribution

  • 00815440020453 ()
200-21045

  • Robotic surgical arm system

Senhance - 00815440020446

Adapter, Passive Babcock Forceps, Long
Asensus Surgical, Inc.
X9007018
In Commercial Distribution

  • 00815440020446 ()
200-21022

  • Robotic surgical arm system

Senhance - 00815440020439

Adapter, Passive Babcock Forceps
Asensus Surgical, Inc.
X9007017
In Commercial Distribution

  • 00815440020439 ()
200-21018

  • Robotic surgical arm system

Senhance - 00815440020415

Adapter, Mixter Dissector
Asensus Surgical, Inc.
X9007014
In Commercial Distribution

  • 00815440020415 ()
200-21042

  • Robotic surgical arm system

Senhance - 00815440020392

Adapter, Strong Grasper
Asensus Surgical, Inc.
X9007011
In Commercial Distribution

  • 00815440020392 ()
200-21038

  • Robotic surgical arm system

Senhance - 00815440020378

Adapter, Kocher Grasper
Asensus Surgical, Inc.
X9007008
In Commercial Distribution

  • 00815440020378 ()
200-21034

  • Robotic surgical arm system

Senhance - 00815440020354

Adapter, Johan Grasper 15mm
Asensus Surgical, Inc.
X9007005
In Commercial Distribution

  • 00815440020354 ()
200-21030

  • Robotic surgical arm system

Senhance - 00815440020347

Adapter, Allis Grasper, Long
Asensus Surgical, Inc.
X9007003
In Commercial Distribution

  • 00815440020347 ()
200-21052

  • Robotic surgical arm system

Senhance - 00815440020330

Adapter, Allis Grasper
Asensus Surgical, Inc.
X9007002
In Commercial Distribution

  • 00815440020330 ()
200-21026

  • Robotic surgical arm system

Senhance - 00815440020323

Stryker Advanced Imaging 10 mm Endoscope Adapter
Asensus Surgical, Inc.
X9007601
In Commercial Distribution

  • 00815440020323 ()
500-21011

  • Robotic surgical arm system

Senhance - 00815440020316

Senhance Node
Asensus Surgical, Inc.
X9000007
In Commercial Distribution

  • 00815440020316 ()
100-01012

  • Robotic surgical arm system

Senhance - 00815440020286

Senhance Cockpit
Asensus Surgical, Inc.
X9007626
In Commercial Distribution

  • 00815440020286 ()
100-01017

  • Robotic surgical arm system

Senhance - 00815440020279

Weck® Hem-o-lok® ML Clip Applier, Long
Asensus Surgical, Inc.
X0007042
In Commercial Distribution

  • 00815440020279 ()

  • Length: 410 Millimeter
  • Outer Diameter: 5 Millimeter
230-11014

  • Robotic surgical forceps, reusable

Senhance - 00815440020262

Weck® Hem-o-lok® ML Clip Applier
Asensus Surgical, Inc.
X0007041
In Commercial Distribution

  • 00815440020262 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
230-11010

  • Robotic surgical forceps, reusable

Senhance - 00815440020248

Fundus Grasper
Asensus Surgical, Inc.
X0007038
In Commercial Distribution

  • 00815440020248 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
200-11050

  • Robotic surgical forceps, reusable

Senhance - 00815440020224

Monopolar L-Hook Electrode
Asensus Surgical, Inc.
X0007035
In Commercial Distribution

  • 00815440020224 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
210-11030

  • Robotic electrosurgical instrument, monopolar, reusable

Senhance - 00815440020187

Monopolar Curved Metzenbaum Scissors Short Tip
Asensus Surgical, Inc.
X0007029
In Commercial Distribution

  • 00815440020187 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
210-11022

  • Robotic electrosurgical instrument, monopolar, reusable

Senhance - 00815440020163

Monopolar Curved Metzenbaum Scissors
Asensus Surgical, Inc.
X0007026
In Commercial Distribution

  • 00815440020163 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
210-11018

  • Robotic electrosurgical instrument, monopolar, reusable

Senhance - 00815440020149

Needle Holder Left
Asensus Surgical, Inc.
X0007023
In Commercial Distribution

  • 00815440020149 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
200-11048

  • Robotic surgical forceps, reusable

Senhance - 00815440020026

Johan Grasper 15mm
Asensus Surgical, Inc.
X0007005
In Commercial Distribution

  • 00815440020026 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
200-11030

  • Robotic surgical forceps, reusable

Senhance - 00815440020002

Allis Grasper
Asensus Surgical, Inc.
X0007002
In Commercial Distribution

  • 00815440020002 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
200-11026

  • Robotic surgical forceps, reusable

Senhance - 00815440020798

Bipolar Curved Grasping Forceps
Asensus Surgical, Inc.
X0005147
In Commercial Distribution

  • 00815440020798 ()

  • Length: 310 Millimeter
  • Outer Diameter: 5 Millimeter
220-11015

  • Robotic electrosurgical instrument, bipolar, reusable

Senhance - 00815440020705

Monopolar Metzenbaum Scissors
Asensus Surgical, Inc.
X0007215
In Commercial Distribution

  • 00815440020705 ()

  • Length: 280 Millimeter
  • Outer Diameter: 3 Millimeter
210-11012

  • Robotic electrosurgical instrument, monopolar, reusable

Senhance - 00815440020682

Monopolar Maryland Dissector
Asensus Surgical, Inc.
X0007212
In Commercial Distribution

  • 00815440020682 ()

  • Length: 280 Millimeter
  • Outer Diameter: 3 Millimeter
210-11010

  • Robotic electrosurgical instrument, monopolar, reusable

Senhance - 00815440020668

DeBakey Grasper
Asensus Surgical, Inc.
X0007209
In Commercial Distribution

  • 00815440020668 ()

  • Length: 280 Millimeter
  • Outer Diameter: 3 Millimeter
200-11014

  • Robotic surgical forceps, reusable

Senhance - 00815440020644

Cobra Grasper
Asensus Surgical, Inc.
X0007206
In Commercial Distribution

  • 00815440020644 ()

  • Length: 280 Millimeter
  • Outer Diameter: 3 Millimeter
200-11012

  • Robotic surgical forceps, reusable

Senhance - 00815440020620

Atraumatic Single Action Grasper
Asensus Surgical, Inc.
X0007203
In Commercial Distribution

  • 00815440020620 ()

  • Length: 280 Millimeter
  • Outer Diameter: 3 Millimeter
200-11010

  • Robotic surgical forceps, reusable

Senhance - 00815440020606

Adapter, Fundus Grasper, Long
Asensus Surgical, Inc.
X9007039
In Commercial Distribution

  • 00815440020606 ()
200-21066

  • Robotic surgical arm system

Senhance - 00815440020590

Adapter, Fundus Grasper
Asensus Surgical, Inc.
X9007038
In Commercial Distribution

  • 00815440020590 ()
200-21050

  • Robotic surgical arm system

Senhance - 00815440020583

Adapter, Passive Weck® Hem-o-lok® ML Clip Applier, Long
Asensus Surgical, Inc.
X9007042
In Commercial Distribution

  • 00815440020583 ()
230-21014

  • Robotic surgical arm system

Senhance - 00815440020576

Adapter, Passive Weck® Hem-o-Lok® ML Clip Applier
Asensus Surgical, Inc.
X9007041
In Commercial Distribution

  • 00815440020576 ()
230-21010

  • Robotic surgical arm system

Senhance - 00815440020569

Adapter, Monopolar Curved Metzenbaum Scissors Short Tip, Long
Asensus Surgical, Inc.
X9007030
In Commercial Distribution

  • 00815440020569 ()
210-21034

  • Robotic surgical arm system

Senhance - 00815440020552

Adapter, Monopolar Curved Metzenbaum Scissors Short Tip
Asensus Surgical, Inc.
X9007029
In Commercial Distribution

  • 00815440020552 ()
210-21022

  • Robotic surgical arm system

Senhance - 00815440020538

Adapter, Monopolar L-Hook Electrode
Asensus Surgical, Inc.
X9007035
In Commercial Distribution

  • 00815440020538 ()
210-21030

  • Robotic surgical arm system

Senhance - 00815440020514

Adapter, Monopolar Maryland Dissector
Asensus Surgical, Inc.
X9007032
In Commercial Distribution

  • 00815440020514 ()
210-21026

  • Robotic surgical arm system

Senhance - 00815440020491

Adapter, Monopolar Curved Metzenbaum Scissors
Asensus Surgical, Inc.
X9007026
In Commercial Distribution

  • 00815440020491 ()
210-21018

  • Robotic surgical arm system
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