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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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ORTHOMAP - 07613252450108

ORTHOMAP¿ VERSATILE HIP 2.0 - UPGRADE
Stryker Leibinger GmbH & Co. KG
6007-616-100
In Commercial Distribution

  • 07613252450108 ()
6007-616-100

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252449850

ORTHOMAP¿ VERSATILE HIP 2.0 SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80056
In Commercial Distribution

  • 07613252449850 ()
81-80056

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252449089

ORTHOMAP¿ PRECISION KNEE 5.0 SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80055
In Commercial Distribution

  • 07613252449089 ()
81-80055

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252448778

ORTHOMAP¿ PRECISION KNEE 5.0 - UPGRADE
Stryker Leibinger GmbH & Co. KG
6003-655-100
In Commercial Distribution

  • 07613252448778 ()
6003-655-100

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252448761

ORTHOMAP¿ PRECISION KNEE 5.0 ENABLE
Stryker Leibinger GmbH & Co. KG
6003-655-300
In Commercial Distribution

  • 07613252448761 ()
6003-655-300

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252433538

ORTHOMAP¿ EXPRESS KNEE 2.0 - ENABLE
Stryker Leibinger GmbH & Co. KG
6003-672-300
In Commercial Distribution

  • 07613252433538 ()
6003-672-300

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252433521

ORTHOMAP¿ EXPRESS KNEE 2.0 - UPGRADE
Stryker Leibinger GmbH & Co. KG
6003-672-100
In Commercial Distribution

  • 07613252433521 ()
6003-672-100

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252355717

ORTHOMAP¿ EXPRESS KNEE 2.0 - SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80050
In Commercial Distribution

  • 07613252355717 ()
81-80050

  • Robotic surgical navigation system application software

FLUOROMAP - 07613252196259

FLUOROMAP 1.0 - SALES DEMO CD
Stryker Leibinger GmbH & Co. KG
81-81022
In Commercial Distribution

  • 07613252196259 ()
81-81022

  • Robotic surgical navigation system application software

Symmetry Shea - 00887482040355

Symmetry® Hook, Shea Stapes, 20° Angle, 0.5 mm
SYMMETRY SURGICAL INC.
62-0445
In Commercial Distribution

  • 00887482040355 ()

  • Angle: 20 degree
  • Width: 0.5 Millimeter
62-0445

  • Robotic surgical navigation system application software

DYONICS 25 - 00885554013597

DYONICS 25 SOFTWARE UPGRADE V1.4
Smith & Nephew, Inc.
72200875
Not in Commercial Distribution

  • 00885554013597 ()
72200875

  • Robotic surgical navigation system application software

ApolloHipX - 05056139249501

ApolloHipX
CORIN LTD
THR.SS.0001
In Commercial Distribution

  • 05056139249501 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960068

iotaSOFT Plus Drive Unit
Iotamotion, Inc.
IM-05
In Commercial Distribution

  • 00850002960068 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960051

iotaSOFT Control Console
Iotamotion, Inc.
IM-01
In Commercial Distribution

  • 00850002960051 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960044

iotaSOFT Rolling Stand
Iotamotion, Inc.
IM-04
In Commercial Distribution

  • 00850002960044 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960037

iotaSOFT Footpedal
Iotamotion, Inc.
IM-03
In Commercial Distribution

  • 00850002960037 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960020

iotaSOFT Console
Iotamotion, Inc.
IM-02
In Commercial Distribution

  • 00850002960020 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960006

iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution

  • 00850002960006 ()


  • Robotic surgical system application software

ELMED - 00198506058103

CYSTO GRID MARKER STAINLESS STEEL
ELMED INCORPORATED
83-31000-CC
In Commercial Distribution

  • 00198506058103 ()
83-31000-CC

  • Robotic surgical system application software

ELMED - 00198506001659

GUYON Catheter Guide GUYON cm, 15-1/2"
ELMED INCORPORATED
ST310703939
In Commercial Distribution

  • 00198506001659 ()
ST310703939

  • Robotic surgical system application software

ELMED - 00842180177390

CATHETER GUIDE, STAINLESS STEEL, AUTOCLAVABLE, 4.75MM ROUND (.1870"), KNURLED HANDLE/STOP, 90 DEGREE BEND AT DISTAL END.
ELMED INCORPORATED
13-CG0823
In Commercial Distribution

  • 00842180177390 ()
13-CG0823

  • Robotic surgical system application software

ELMED - 00842180191426

CATHETER GUIDE, STAINLESS STEEL, AUTOCLAVABLE, 4.75MM ROUND (.1870"), KNURLED HANDLE/STOP, 90 DEGREE BEND AT DISTAL END.
ELMED INCORPORATED
ST13CG0823
In Commercial Distribution

  • 00842180191426 ()
ST13CG0823

  • Robotic surgical system application software

Monarch Software Cart v2.2.1 - B634SW0121930202000

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

  • B634SW0121930202000 ()


  • Robotic surgical system application software

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

Monarch™ Laptop P16 Software v4.1.1 - 10810068811527

Monarch™ Laptop P16 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811527 ()


  • Robotic surgical system application software

Monarch™ Laptop P17 Software v4.1.1 - 10810068811510

Monarch™ Laptop P17 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811510 ()


  • Robotic surgical system application software

Monarch™ Tower Software v4.1.1 - 10810068811497

Monarch™ Tower Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811497 ()


  • Robotic surgical system application software

Monarch™ Cart Software v4.1.1 - 10810068811503

Monarch™ Cart Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811503 ()


  • Robotic surgical system application software

Monarch™ Laptop P17/P73 Linux USB Image v2.2.5 - 10810068810797

Monarch™ Laptop P17/P73 Linux USB Image v2.2.5
AURIS HEALTH, INC.
Version 2.2.5
In Commercial Distribution

  • 10810068810797 ()


  • Robotic surgical system application software

Monarch™ Laptop P70 Linux USB Image v2.2.5 - 10810068810780

Monarch™ Laptop P70 Linux USB Image v2.2.5
AURIS HEALTH, INC.
Version 2.2.5
In Commercial Distribution

  • 10810068810780 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.2.5 - 10810068810773

Monarch™ Software Cart v2.2.5
AURIS HEALTH, INC.
Version 2.2.5
In Commercial Distribution

  • 10810068810773 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.2.5 - 10810068810766

Monarch™ Software Tower v2.2.5
AURIS HEALTH, INC.
Version 2.2.5
In Commercial Distribution

  • 10810068810766 ()


  • Robotic surgical system application software

Monarch™ Laptop P16 Software v4.1.0 - 10810068810612

Monarch™ Laptop P16 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810612 ()


  • Robotic surgical system application software

Monarch™ Laptop P17 Software v4.1.0 - 10810068810605

Monarch™ Laptop P17 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810605 ()


  • Robotic surgical system application software

Monarch™ Cart Software v4.1.0 - 10810068810599

Monarch™ Cart Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810599 ()


  • Robotic surgical system application software

Monarch™ Tower Software v4.1.0 - 10810068810582

Monarch™ Tower Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810582 ()


  • Robotic surgical system application software

Monarch™ Laptop P17/P73 Linux USB Image v2.2.4 - 10810068810506

Monarch™ Laptop P17/P73 Linux USB Image v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810506 ()


  • Robotic surgical system application software

Monarch™ Laptop P70 Linux USB Image v2.2.4 - 10810068810490

Monarch™ Laptop P70 Linux USB Image v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810490 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.2.4 - 10810068810483

Monarch™ Software Cart v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810483 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.2.4 - 10810068810476

Monarch™ Software Tower v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810476 ()


  • Robotic surgical system application software
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