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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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HandX - 07290017376004

The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.
HUMAN XTENSIONS LTD
20-30-019-01
In Commercial Distribution

  • 17290017376001 ()
  • 07290017376004 ()
20-30-019-01

  • Endoscopic electromechanical surgical system

HandX Disposables - 07290017376035

HandX Disposables include 1 Arc&Pads pouch and 1 DC Power Cable
HUMAN XTENSIONS LTD
20-30-008-01
In Commercial Distribution

  • 17290017376032 ()
  • 07290017376035 ()
20-30-009-01

  • Endoscopic electromechanical surgical system

HandX Needle Holder 5mm - 07290017376028

No Description
HUMAN XTENSIONS LTD
20-30-011-01
In Commercial Distribution

  • 17290017376025 ()
  • 07290017376028 ()

  • Outer Diameter: 5 Millimeter
20-30-014-01

  • Endoscopic electromechanical surgical system

HandX Fenestrated Grasper 5mm - 07290017376011

No Description
HUMAN XTENSIONS LTD
20-30-013-01
In Commercial Distribution

  • 17290017376018 ()
  • 07290017376011 ()

  • Outer Diameter: 5 Millimeter
20-30-015-01

  • Endoscopic electromechanical surgical system

Single-Site - 00886874117293

SUCTION IRRIGATOR
INTUITIVE SURGICAL, INC.
428054
In Commercial Distribution

  • 00886874117293 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical irrigation/aspiration cannula, reusable

Single-Site - 00886874113707

BIPOLAR MARYLAND
INTUITIVE SURGICAL, INC.
478080
In Commercial Distribution

  • 10886874113704 ()
  • 00886874113707 ()

  • Outer Diameter: 5 Millimeter


  • Robotic electrosurgical instrument, bipolar, single-use

Single-Site - 00886874113677

ENDOSCOPE PORT
INTUITIVE SURGICAL, INC.
478065
In Commercial Distribution

  • 10886874113674 ()
  • 00886874113677 ()

  • Lumen/Inner Diameter: 5 Millimeter


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Single-Site - 00886874112724

CANNULA SEAL
INTUITIVE SURGICAL, INC.
478161
In Commercial Distribution

  • 30886874112725 ()
  • 10886874112721 ()
  • 00886874112724 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 5 Millimeter


  • Laparoscopic access cannula seal, single-use

EndoWrist - 00886874112069

BIPOLAR MARYLAND
INTUITIVE SURGICAL, INC.
428080
In Commercial Distribution

  • 10886874112066 ()
  • 00886874112069 ()

  • Outer Diameter: 5 Millimeter


  • Robotic electrosurgical instrument, bipolar, single-use

Single-Site; daVinci Si - 00886874111918

SUCTION IRRIGATOR
INTUITIVE SURGICAL, INC.
428054
In Commercial Distribution

  • 00886874111918 ()

  • Outer Diameter: 5 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable
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