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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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Scopis ENT - 07613327413243

Scopis ENT Software
Stryker Leibinger GmbH & Co. KG
8000-020-001
In Commercial Distribution

  • 07613327413243 ()
8000-020-001

  • Stereotactic system application software

Scopis ENT - 07613327413199

Scopis ENT Software with Target Guided Surgery
Stryker Leibinger GmbH & Co. KG
8000-020-002
In Commercial Distribution

  • 07613327413199 ()
8000-020-002

  • Stereotactic system application software

Surveyor Central - 00812345028140

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCREV-AAA-BXXXX
Not in Commercial Distribution

  • 00812345028140 ()


  • Cardiology information system

Surveyor Central - 00812345028133

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCREV-AAA-BXXAX
Not in Commercial Distribution

  • 00812345028133 ()


  • Cardiology information system

Scopis - 07613327514179

ENT Software with TGS
Stryker Leibinger GmbH & Co. KG
8000-021-002
In Commercial Distribution

  • 07613327514179 ()
8000-021-002

  • Stereotactic system application software

Scopis - 07613327513950

Planning Software
Stryker Leibinger GmbH & Co. KG
8000-021-005
In Commercial Distribution

  • 07613327513950 ()
8000-021-005

  • Stereotactic system application software

Scopis - 07613327513943

ENT Software
Stryker Leibinger GmbH & Co. KG
8000-021-001
In Commercial Distribution

  • 07613327513943 ()
8000-021-001

  • Stereotactic system application software

NOVA Basic - B057U40140

The Navigation Software NOVA Basic provides import of image sets, building the image-based model of patient anatomy, planning of surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.8
In Commercial Distribution

  • B057U40140 ()
U4 014

  • Stereotactic system application software

NOVA AR - B057U4003260170

The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.17
In Commercial Distribution

  • B057U4003260170 ()
U4 003

  • Stereotactic system application software

NOVA AR - B057U4003260160

The Navigation Software NOCA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.16
In Commercial Distribution

  • B057U4003260160 ()
U4 003

  • Stereotactic system application software
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