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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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XperGuide - 00884838059252

Software medical device, used with a Philips Interventional X-Ray System. Extension of XperCT. Intended to assist the user during percutaneous interventions by providing live 3D needle image guidance.
Philips Medical Systems Nederland B.V.
XperGuide - 1
In Commercial Distribution

  • 00884838059252 ()
001006

  • Angiographic x-ray system application software

Allura 3D-CA - 00884838059245

Software medical device, used with a Philips Interventional X-Ray System. Creates a 3D model of the coronary vessel tree from a pair of 2D images from a rotational angiographic run.
Philips Medical Systems Nederland B.V.
Allura 3D-CA - 3
In Commercial Distribution

  • 00884838059245 ()
001009

  • Angiographic x-ray system application software

MR-CT Roadmap - 00884838059238

Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Provides live 3D image guidance for navigating endovascular devices through vascular structures.
Philips Medical Systems Nederland B.V.
MR-CT Roadmap - 1
In Commercial Distribution

  • 00884838059238 ()
001004

  • Angiographic x-ray system application software

3D Roadmap - 00884838059221

Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Superimposes live fluoroscopic images on a 3D reconstruction of the vessel anatomy.
Philips Medical Systems Nederland B.V.
3D Roadmap - 1
In Commercial Distribution

  • 00884838059221 ()
001003

  • Angiographic x-ray system application software

HeartNavigator - 00884838059207

Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques.
Philips Medical Systems Nederland B.V.
HeartNavigator - 2
In Commercial Distribution

  • 00884838059207 ()
001001

  • Angiographic x-ray system application software

Interventional Workspot - 00884838059191

Software medical device hosting platform, used with a Philips Interventional X-Ray System. Provides common functionalities (e.g. import / export, data handling) for other software medical devices.
Philips Medical Systems Nederland B.V.
Interventional Workspot - 1
In Commercial Distribution

  • 00884838059191 ()
001000

  • Angiographic x-ray system application software

EP navigator - 00884838059184

Software medical device, used with a Philips Interventional X-Ray System. Provides navigation support for cardiovascular devices for heart rhythm disorders.
Philips Medical Systems Nederland B.V.
EP navigator - 5
In Commercial Distribution

  • 00884838059184 ()
000071

  • Angiographic x-ray system application software

NA - 00885556568545

REFURBTUBESIZING 7.5MM
Smith & Nephew, Inc.
7207164D
Not in Commercial Distribution

  • 00885556568545 ()
7207164D

  • Ligament graft sizer, noninvasive

NA - 00885556568538

REFURBTUBESIZING 6.5MM
Smith & Nephew, Inc.
7207163D
Not in Commercial Distribution

  • 00885556568538 ()
7207163D

  • Ligament graft sizer, noninvasive

First Responder - 00743537001439

First Responder Heat Shield 8'x6', 4 Canisters/cs, Grainger; BD Gel
WATER-JEL TECHNOLOGIES, L.L.C.
G9672C-4.69.000
In Commercial Distribution

  • 00743537000555 ()
  • 00743537001439 ()
G9672C-4.69.000

  • Pure wool burn sheet
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