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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 Endoscopy Platform (P1) Tower Upgrade - B634MON00000501

Monarch Endoscopy Platform (P1) Tower Upgrade
AURIS HEALTH, INC.
MON-000005-01
Not in Commercial Distribution

  • B634MON00000501 ()


  • 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

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

Tsolution One Surgical System - M9461076450

CUTTER DRIVE ASSEMBLY, TCAT
THINK SURGICAL, INC.
107645
In Commercial Distribution

  • M9461076450 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076440

REAMER/IMPACTOR HOLDER
THINK SURGICAL, INC.
107644
In Commercial Distribution

  • M9461076440 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461076420

COUPLER, MASTER SIDE
THINK SURGICAL, INC.
107642
In Commercial Distribution

  • M9461076420 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461063820

ASSY, PERCUTANEOUS PROBE HUB
THINK SURGICAL, INC.
106382
In Commercial Distribution

  • M9461063820 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M946106298040

THREADED DIGITIZER PROBE, BALL TIP
THINK SURGICAL, INC.
106298-04
In Commercial Distribution

  • M946106298040 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M946106298030

THREADED DIGITIZER PROBE, TAPERED TROCHAR TIP
THINK SURGICAL, INC.
106298-03
In Commercial Distribution

  • M946106298030 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461062190

HOFFMAN ADAPTER ROD
THINK SURGICAL, INC.
106219
In Commercial Distribution

  • M9461062190 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461059340

SURGERY SUPPOR KIT, THA Cup US, 10 PACKS / CARTON
THINK SURGICAL, INC.
105934
In Commercial Distribution

  • M9461059340 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461057170

TCAT THA Instrument Kit, Cup
THINK SURGICAL, INC.
105717
In Commercial Distribution

  • M9461057170 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461057160

WRENCH, 2.5mm HEX, 465 SS
THINK SURGICAL, INC.
105716
In Commercial Distribution

  • M9461057160 ()

  • Width: 2.5 Millimeter


  • Robotic surgical arm system

Tsolution One Surgical System - M9461056530

ASSY, BEARING SLEEVE TCAT THA
THINK SURGICAL, INC.
105653
In Commercial Distribution

  • M9461056530 ()


  • Robotic surgical arm system

Tsolution One Surgical System - M9461049480

ASSEMBLY, BMM SMART PROBE, ADJUSTABLE
THINK SURGICAL, INC.
104948
In Commercial Distribution

  • M9461049480 ()


  • Robotic surgical arm system
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