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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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Precision Targeting Arm
Stryker Leibinger GmbH & Co. KG
6000-801-000
In Commercial Distribution

  • 07613327467222 ()
6000-801-000

  • Surgical planning/navigation-enhancement system
Tracker Sleeve
Stryker Leibinger GmbH & Co. KG
6000-803-000
In Commercial Distribution

  • 07613327467215 ()
6000-803-000

  • Surgical planning/navigation-enhancement system
Precision Targeting Guide
Stryker Leibinger GmbH & Co. KG
6000-802-000
In Commercial Distribution

  • 07613327467208 ()
6000-802-000

  • Surgical planning/navigation-enhancement system
No Description
Ambra Health
3.16.10.0
In Commercial Distribution

  • AMBRHEALTHSOLUTIONS0 ()


  • Radiology information system
No Description
Ambra Health
3.24
In Commercial Distribution

  • AMBRAPACS0 ()


  • Radiology information system
Mobile Application version of Ambra Health. Not intended for diagnostic purposes.
Ambra Health
AMBRMOBILEAPP0
In Commercial Distribution

  • AMBRMOBILEAPP0 ()


  • Radiology information system
ADAPT Gamma3 DTS Clip
Stryker GmbH
1320-8201
In Commercial Distribution

  • 07613327298192 ()
1320-8201

  • Medical image management system
PC Set
Stryker Leibinger GmbH & Co. KG
0101-2000
In Commercial Distribution

  • 07613327312430 ()
0101-2000

  • Medical image management system
PC Unit
Stryker Leibinger GmbH & Co. KG
0101-2900
In Commercial Distribution

  • 07613327312393 ()
0101-2900

  • Medical image management system
ADAPT 2.0 for Gamma3 Software
Stryker GmbH
0101-0001
In Commercial Distribution

  • 07613327311822 ()
0101-0001

  • Medical image management system
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