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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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Monopolar L-Hook Electrode
Asensus Surgical, Inc.
X0007176
In Commercial Distribution

  • 00815440021887 ()

  • Length: 240 Millimeter
  • Outer Diameter: 5 Millimeter
210-11011

  • Robotic electrosurgical instrument, monopolar, reusable
Senhance® Needle Driver, Articulating (US)
Asensus Surgical, Inc.
X9007675
In Commercial Distribution

  • 00815440021856 ()


  • Robotic surgical arm system
Senhance® Bipolar Atraumatic Grasper, Articulating (US)
Asensus Surgical, Inc.
X9007672
In Commercial Distribution

  • 00815440021825 ()


  • Robotic surgical arm system
KARL STORZ 3DHD 10 mm Endoscope Adapter
Asensus Surgical, Inc.
X9007661
In Commercial Distribution

  • 00815440021764 ()
500-21015

  • Robotic surgical arm system
KARL STORZ 5 mm Endoscope Adapter
Asensus Surgical, Inc.
X9007660
In Commercial Distribution

  • 00815440021757 ()
500-21016

  • Robotic surgical arm system
KARL STORZ 10 mm Endoscope Adapter
Asensus Surgical, Inc.
X9007649
In Commercial Distribution

  • 00815440021740 ()
500-21017

  • Robotic surgical arm system
Bipolar Curved Scissors
Asensus Surgical, Inc.
X0007516
In Commercial Distribution

  • 00815440021696 ()

  • Length: 250 Millimeter
  • Outer Diameter: 5 Millimeter
220-11031

  • Robotic electrosurgical instrument, bipolar, reusable
Bipolar Maryland Dissector
Asensus Surgical, Inc.
X0007513
In Commercial Distribution

  • 00815440021689 ()

  • Length: 250 Millimeter
  • Outer Diameter: 5 Millimeter
220-11029

  • Robotic electrosurgical instrument, bipolar, reusable
Bipolar Curved Grasping Forceps
Asensus Surgical, Inc.
X0007510
In Commercial Distribution

  • 00815440021672 ()

  • Length: 250 Millimeter
  • Outer Diameter: 5 Millimeter
220-11025

  • Robotic electrosurgical instrument, bipolar, reusable
Bipolar Large Grasping Forceps
Asensus Surgical, Inc.
X0007507
In Commercial Distribution

  • 00815440021665 ()

  • Length: 250 Millimeter
  • Outer Diameter: 5 Millimeter
220-11027

  • Robotic electrosurgical instrument, bipolar, reusable
Bipolar Shaft
Asensus Surgical, Inc.
X0007504
In Commercial Distribution

  • 00815440021658 ()

  • Length: 250 Millimeter
  • Outer Diameter: 5 Millimeter
220-11033

  • Robotic electrosurgical instrument, bipolar, reusable
Bipolar Shaft
Asensus Surgical, Inc.
X0007303
In Commercial Distribution

  • 00815440021641 ()

  • Length: 280 Millimeter
  • Outer Diameter: 3 Millimeter
220-11014

  • Robotic electrosurgical instrument, bipolar, reusable
Bipolar Grasping Forceps
Asensus Surgical, Inc.
X0007306
In Commercial Distribution

  • 00815440021627 ()

  • Length: 280 Millimeter
  • Outer Diameter: 3 Millimeter
220-11012

  • Robotic electrosurgical instrument, bipolar, reusable
Senhance Ultrasonic Footswitch
Asensus Surgical, Inc.
X9007641
In Commercial Distribution

  • 00815440021597 ()
300-01012

  • Foot-switch, pneumatic
Senhance Ultrasonic Generator
Asensus Surgical, Inc.
X9007621
In Commercial Distribution

  • 00815440021580 ()
300-01010

  • Electrosurgical/ultrasonic surgical system generator
Senhance Ultrasonic Transducer
Asensus Surgical, Inc.
X9007620
In Commercial Distribution

  • 00815440021573 ()
300-11011

  • Soft-tissue ultrasonic surgical system transducer/tip
Senhance Ultrasonic Dissector
Asensus Surgical, Inc.
X9007619
In Commercial Distribution

  • 00815440021566 ()
  • 10815440021563 ()
300-11010

  • Soft-tissue ultrasonic robotic surgical instrument, single-use
Adapter, Bipolar Curved Scissors
Asensus Surgical, Inc.
X9007516
In Commercial Distribution

  • 00815440021498 ()
220-21031

  • Robotic surgical arm system
Adapter, Bipolar Maryland Dissector
Asensus Surgical, Inc.
X9007513
In Commercial Distribution

  • 00815440021481 ()
220-21029

  • Robotic surgical arm system
Adapter, Bipolar Curved Grasping Forceps
Asensus Surgical, Inc.
X9007510
In Commercial Distribution

  • 00815440021474 ()
220-21025

  • Robotic surgical arm system
Adapter, Bipolar Large Grasping Forceps
Asensus Surgical, Inc.
X9007507
In Commercial Distribution

  • 00815440021467 ()
220-21027

  • Robotic surgical arm system
Adapter, Bipolar Maryland Dissector
Asensus Surgical, Inc.
X9007309
In Commercial Distribution

  • 00815440021450 ()
220-21010

  • Robotic surgical arm system
Adapter, Bipolar Grasping Forceps
Asensus Surgical, Inc.
X9007306
In Commercial Distribution

  • 00815440021443 ()
220-21012

  • Robotic surgical arm system
Adapter, Passive Weck® Hem-o-lok® ML Clip Applier
Asensus Surgical, Inc.
X9007040
In Commercial Distribution

  • 00815440021429 ()
230-21018

  • Robotic surgical arm system
Adapter, Passive Fundus Grasper
Asensus Surgical, Inc.
X9007037
In Commercial Distribution

  • 00815440021412 ()
200-21096

  • Robotic surgical arm system
Adapter, Monopolar L-Hook Electrode
Asensus Surgical, Inc.
X9007034
In Commercial Distribution

  • 00815440021405 ()
210-21011

  • Robotic surgical arm system
Adapter, Monopolar Maryland Dissector
Asensus Surgical, Inc.
X9007031
In Commercial Distribution

  • 00815440021399 ()
210-21046

  • Robotic surgical arm system
Adapter, Monopolar Metzenbaum Scissors 15 mm Tip
Asensus Surgical, Inc.
X9007028
In Commercial Distribution

  • 00815440021382 ()
210-21044

  • Robotic surgical arm system
Adapter, Monopolar Metzenbaum Scissors 18 mm Tip
Asensus Surgical, Inc.
X9007025
In Commercial Distribution

  • 00815440021375 ()
210-21042

  • Robotic surgical arm system
No Description
RESTORATION ROBOTICS, INC.
Cart
In Commercial Distribution

  • 90850470007008 ()
FP-40000

  • Robotic surgical arm system
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