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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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Monarch Endoscopy Platform (P1) Tower Upgrade - B634MON000005010

Monarch Endoscopy Platform (P1) Tower Upgrade
AURIS HEALTH, INC.
MON-000005-01
In Commercial Distribution

  • B634MON000005010 ()


  • Robotic surgical arm system

Monarch™ Platform - B634MON0000050

The Monarch Platform enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON000005
In Commercial Distribution

  • B634MON0000050 ()
MON000005

  • Robotic surgical arm system

OmnisEMG - B179OMNI13E87E4

Biomechanical function analysis / interactive rehabilitation system
ACCELERATED CARE PLUS CORP
44144
In Commercial Distribution

  • B179OMNI13E87E4 ()


  • Biomechanical function analysis/interactive rehabilitation system

Dexter L6 Robot - 07640184840516

Dexter L6 - Patient Cart 1 Dexter L6 - Patient Cart 2 Dexter L6 - Surgeon Console
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840516 ()
710

  • Robotic surgical arm system

Dexter Monopolar Hook - 07640184840493

Dexter L6 Monopolar Hook
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840509 ()
  • 07640184840493 ()
709

  • Robotic surgical arm system

Dexter Monopolar Scissors - 07640184840479

Dexter L6 Monopolar Scissors
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840486 ()
  • 07640184840479 ()
707

  • Robotic surgical arm system

Dexter Needle Holder - 07640184840455

Dexter L6 Needle Holder
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840462 ()
  • 07640184840455 ()
705

  • Robotic surgical arm system

Dexter Bipolar Johann Grasper - 07640184840431

Dexter L6 Bipolar Johann Grasper
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840448 ()
  • 07640184840431 ()
703

  • Robotic surgical arm system

Dexter Bipolar Maryland Dissector - 07640184840417

Dexter L6 Bipolar Maryland Dissector
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840424 ()
  • 07640184840417 ()
701

  • Robotic surgical arm system

Dexter Sterile Interface - 07640184840233

Dexter L6 Sterile Interface
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840240 ()
  • 07640184840233 ()
140

  • Robotic surgical arm system

Dexter L6 Endoscope Cart - 07640184840219

Dexter L6 Endoscope Cart
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840226 ()
  • 07640184840219 ()
339

  • Robotic surgical arm system

Dexter L6 Emergency Release Tool - 07640184840196

Dexter L6 Emergency Release Tool
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840400 ()
  • 07640184840196 ()
487

  • Robotic surgical arm system

Dexter L6 Incision Pointer - 07640184840172

Dexter L6 Incision Pointer
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840189 ()
  • 07640184840172 ()
413

  • Robotic surgical arm system

Dexter L6 Handle Grip - 07640184840158

Dexter L6 Handle Grip
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840158 ()
  • 07640184840165 ()
146

  • Robotic surgical arm system

Dexter L6 Accessory tray - 07640184840134

Dexter L6 Accessory tray
Distalmotion SA
Dexter L6
In Commercial Distribution

  • 07640184840141 ()
  • 07640184840134 ()
147

  • Robotic surgical arm system

Tsolution One Surgical System - M9461082000

ASSEMBLY, TCAT™ 200, 100-240V
THINK SURGICAL, INC.
108200
In Commercial Distribution

  • M9461082000 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076660

REAMER DRIVER, ACETABULAR CUP, 001
THINK SURGICAL, INC.
107666
In Commercial Distribution

  • M9461076660 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076650

REAMER DRIVER SLEEVE
THINK SURGICAL, INC.
107665
In Commercial Distribution

  • M9461076650 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076500

BEARING SLEEVE, IMPACTOR
THINK SURGICAL, INC.
107650
In Commercial Distribution

  • M9461076500 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076490

BEARING SLEEVE, REAMER DRIVER
THINK SURGICAL, INC.
107649
In Commercial Distribution

  • M9461076490 ()


  • Robotic surgical arm system
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