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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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NA - 07613154637164

FLUOROSCOPY SOFTWARE 2.3 - ENABLE
Stryker Leibinger GmbH & Co. KG
6004-650-300
In Commercial Distribution

  • 07613154637164 ()
6004-650-300

  • Robotic surgical navigation system application software

ROSA® Shoulder - 00887868558306

No Description
Orthosoft Inc
20-8087-700-00
In Commercial Distribution

  • 00887868558306 ()
20808770000

  • Robotic surgical navigation system application software

PROFESS - 07613327286755

PROFESS(TM) SOFTWARE ENABLE
Stryker Leibinger GmbH & Co. KG
6001-400-300
In Commercial Distribution

  • 07613327286755 ()
6001-400-300

  • Robotic surgical navigation system application software

Mako - 07613327395341

No Description
MAKO SURGICAL CORP.
213951
In Commercial Distribution

  • 07613327395341 ()
213951

  • Robotic surgical navigation system application software

NA - 07613327115048

FLUOROSCOPY SOFTWARE 2.3 CD
Stryker Leibinger GmbH & Co. KG
81-80036
In Commercial Distribution

  • 07613327115048 ()
81-80036

  • Robotic surgical navigation system application software

SPINEMAP - 07613327115017

SPINEMAP¿ 3D 3.0 - ENABLE
Stryker Leibinger GmbH & Co. KG
6002-670-300
In Commercial Distribution

  • 07613327115017 ()
6002-670-300

  • Robotic surgical navigation system application software

SPINEMAP - 07613327114935

SPINEMAP¿ 3D 3.0 - UPGRADE
Stryker Leibinger GmbH & Co. KG
6002-670-100
In Commercial Distribution

  • 07613327114935 ()
6002-670-100

  • Robotic surgical navigation system application software

SPINEMAP - 07613327114898

SPINEMAP¿ 3D 3.0 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-670-000
In Commercial Distribution

  • 07613327114898 ()
6002-670-000

  • Robotic surgical navigation system application software

SPINEMAP - 07613327115055

SPINEMAP¿ 3D 3.0 - SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81000
In Commercial Distribution

  • 07613327115055 ()
81-81000

  • 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

Crypto/Giardia Human Fecal Direct Fluorescent Antigen Detection Kit - 00854624006005

No Description
IVD RESEARCH, INC.
C/G-DFA
In Commercial Distribution

  • 00854624006005 ()
C/G-DFA

  • Cryptosporidium species antigen IVD, kit, direct fluorescent test (DFT)
  • Giardia lamblia antigen IVD, kit, direct fluorescent test (DFT)

ApolloHipX - 05056139249501

ApolloHipX
CORIN LTD
THR.SS.0001
In Commercial Distribution

  • 05056139249501 ()


  • 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

ELMED - 00198506058103

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

  • 00198506058103 ()
83-31000-CC

  • 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

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™ 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™ 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™ 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

ELMED - 00198506001659

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

  • 00198506001659 ()
ST310703939

  • 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
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