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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 Software Tower v2.2.1 - B634SW0121920202000

Monarch Software Tower v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution

  • B634SW0121920202000 ()


  • Robotic surgical system application software

Monarch Software Cart v2.1.6 - B634SW0121890201060

Monarch Software Cart v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121890201060 ()


  • Robotic surgical system application software

Monarch Software Tower v2.1.6 - B634SW0121880201060

Monarch Software Tower v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121880201060 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.1.5 - B634SW0032750201050

Monarch™ Software Cart v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032750201050 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.1.4 - B634SW0032750201040

Monarch™ Software Cart v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032750201040 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.1.3 - B634SW0032750201030

Monarch™ Software Cart v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032750201030 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.1.2 - B634SW0032750201020

Monarch™ Software Cart v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032750201020 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.1.5 - B634SW0032740201050

Monarch™ Software Tower v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032740201050 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.1.4 - B634SW0032740201040

Monarch™ Software Tower v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032740201040 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.1.3 - B634SW0032740201030

Monarch™ Software Tower v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032740201030 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.1.2 - B634SW0032740201020

Monarch™ Software Tower v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032740201020 ()


  • Robotic surgical system application software

Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX - 00850470007630

No Description
RESTORATION ROBOTICS, INC.
19G
In Commercial Distribution

  • 00850470007630 ()
FP-102778

  • Hair extraction punch

Disposable Kit, Sterile and Non Sterile, iX - 00850470007579

No Description
RESTORATION ROBOTICS, INC.
19G 4 Prong
In Commercial Distribution

  • 00850470007579 ()
FP-102769

  • Hair extraction punch

ARTAS iX - 00850470007531

No Description
RESTORATION ROBOTICS, INC.
Chair
In Commercial Distribution

  • 00850470007531 ()
FP-47000

  • Robotic surgical arm system

Disposable Kits, Sterile and Non-Sterile (S) - 00850470007517

No Description
RESTORATION ROBOTICS, INC.
20G 4 Prong
In Commercial Distribution

  • 00850470007517 ()


  • Hair extraction punch

Disposable Kits, Sterile and Non-Sterile (S) - 00850470007494

No Description
RESTORATION ROBOTICS, INC.
19G 4 Prong
In Commercial Distribution

  • 00850470007494 ()


  • Hair extraction punch

Disposable Kits, Sterile and Non-Sterile (S) - 00850470007470

No Description
RESTORATION ROBOTICS, INC.
18G 4 Prong
In Commercial Distribution

  • 00850470007470 ()


  • Hair extraction punch

Disposable Kits, Sterile and Non-Sterile (S) - 00850470007432

No Description
RESTORATION ROBOTICS, INC.
19G 2 Prong
In Commercial Distribution

  • 00850470007432 ()


  • Hair extraction punch

Disposable Kits, Sterile and Non-Sterile - 00850470007418

No Description
RESTORATION ROBOTICS, INC.
18G 2 Prong
In Commercial Distribution

  • 00850470007418 ()


  • Hair extraction punch

Disposable Kits - 00850470007357

No Description
RESTORATION ROBOTICS, INC.
19G 4 Prong 4mm Punch
In Commercial Distribution

  • 00850470007357 ()
FP-47843

  • Hair extraction punch

Disposable Kit - 00850470007333

No Description
RESTORATION ROBOTICS, INC.
19G 4 Prong 4mm Punch, Sterile
In Commercial Distribution

  • 00850470007333 ()
FP-47842

  • Hair extraction punch

Disposable Kits, 20G - 00850470007319

No Description
RESTORATION ROBOTICS, INC.
4 prong 6mm punch
In Commercial Distribution

  • 00850470007319 ()
FP-101284

  • Hair extraction punch

Disposable Kits, 20G - 00850470007296

No Description
RESTORATION ROBOTICS, INC.
2 prong 6mm punch
In Commercial Distribution

  • 00850470007296 ()
FP-101282

  • Hair extraction punch

Reusable Kit - 00850470007241

No Description
RESTORATION ROBOTICS, INC.
Site Making
In Commercial Distribution

  • 00850470007241 ()
FP-46446

  • Hair extraction punch

Disposable Kit - 00850470007227

No Description
RESTORATION ROBOTICS, INC.
Non-Sterile Site Making
In Commercial Distribution

  • 00850470007227 ()
FP-47059

  • Hair extraction punch

Disposable Kit - 00850470007203

No Description
RESTORATION ROBOTICS, INC.
Site Making
In Commercial Distribution

  • 00850470007203 ()
FP-47060

  • Hair extraction punch

Disposable Accessories Kit - 00850470007180

No Description
RESTORATION ROBOTICS, INC.
19G 2 Prong 6mm Punch
In Commercial Distribution

  • 00850470007180 ()
FP-100057

  • Hair extraction punch

Disposable Sterile Kit - 00850470007173

No Description
RESTORATION ROBOTICS, INC.
18G 2 Prong 6mm Punch
In Commercial Distribution

  • 00850470007173 ()
FP-100054

  • Hair extraction punch

Disposable Accessories Kit - 00850470007166

No Description
RESTORATION ROBOTICS, INC.
18G 2 Prong 6mm Punch
In Commercial Distribution

  • 00850470007166 ()
FP-100055

  • Hair extraction punch

Disposable Sterile Kit - 00850470007159

No Description
RESTORATION ROBOTICS, INC.
19G 4 Prong 6mm Punch Long Bevel
In Commercial Distribution

  • 00850470007159 ()
FP-100671

  • Hair extraction punch

Disposable Accessories Kit - 00850470007142

No Description
RESTORATION ROBOTICS, INC.
19G 4 Prong 6mm Punch Long Bevel
In Commercial Distribution

  • 00850470007142 ()
FP-100672

  • Hair extraction punch

Disposable Sterile Kit - 00850470007135

No Description
RESTORATION ROBOTICS, INC.
18G 4 Prong 6mm Punch Long Bevel
In Commercial Distribution

  • 00850470007135 ()
FP-100669

  • Hair extraction punch

Disposable Accessories Kit - 00850470007128

No Description
RESTORATION ROBOTICS, INC.
18G 4 Prong 6mm Punch Long Bevel
In Commercial Distribution

  • 00850470007128 ()
FP-100670

  • Hair extraction punch

Disposable Accessories Kit - 00850470007104

No Description
RESTORATION ROBOTICS, INC.
19G 4 Prong 6mm Punch
In Commercial Distribution

  • 00850470007104 ()
FP-100482

  • Hair extraction punch

Disposable Accessories Kit - 00850470007081

No Description
RESTORATION ROBOTICS, INC.
18G 4 Prong 6mm Punch
In Commercial Distribution

  • 00850470007081 ()
FP-100766

  • Hair extraction punch

Disposable Kit - 00850470007074

No Description
RESTORATION ROBOTICS, INC.
19G Sterile
In Commercial Distribution

  • 00850470007074 ()
FP-45717

  • Hair extraction punch

Disposable Accessories Kit - 00850470007067

No Description
RESTORATION ROBOTICS, INC.
19G
In Commercial Distribution

  • 00850470007067 ()
FP-45174

  • Hair extraction punch

Disposable Kit - 00850470007050

No Description
RESTORATION ROBOTICS, INC.
Non-Sterile
In Commercial Distribution

  • 00850470007050 ()
FP-23267

  • Hair extraction punch

Disposable Kit - 00850470007043

No Description
RESTORATION ROBOTICS, INC.
18G Sterile
In Commercial Distribution

  • 00850470007043 ()
FP-45547

  • Hair extraction punch

Disposable Accessories Kit - 00850470007036

No Description
RESTORATION ROBOTICS, INC.
18G
In Commercial Distribution

  • 00850470007036 ()
FP-45173

  • Hair extraction punch
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