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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 Bronchscope 2.0/Monarch Platform (P2) - B634MON0000060

The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. Monarch Bronchscope 2.0/Monarch Platform (P2)
AURIS HEALTH, INC.
MON-000006
In Commercial Distribution

  • B634MON0000060 ()


  • Robotic surgical arm system

Monarch™ Platform (Refurbished) - B634MON000005R0

The Monarch Platform (Refurbished) enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
AURIS HEALTH, INC.
MON000005R
In Commercial Distribution

  • B634MON000005R0 ()
MON000005R

  • Robotic surgical arm system

Monarch Endoscopy Platform (P1) System, Refurbished - B634MON00000501R0

Monarch Endoscopy Platform (P1) System, Refurbished
AURIS HEALTH, INC.
MON-000005-01R
In Commercial Distribution

  • B634MON00000501R0 ()


  • Robotic surgical arm system

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 - M9461076490

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

  • M9461076490 ()


  • Robotic surgical arm system
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