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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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TYSHAK X™ - 04046964313097

TYSHAK-X 8X3X6X6X100X.035 PDC301
B BRAUN INTERVENTIONAL SYSTEMS, INC
618301
Not in Commercial Distribution

  • 04046964313097 ()
618301

  • Cardiac valvuloplasty catheter

TYSHAK X™ - 04046964313073

TYSHAK-X 8X2X6X6X100X.035 PDC300
B BRAUN INTERVENTIONAL SYSTEMS, INC
618300
In Commercial Distribution

  • 04046964313073 ()
618300

  • Cardiac valvuloplasty catheter

Green X 12 - 08800016401844

PHT-75CHS(RC12X8.5)(US)/P(W-PAN P)+C(W-CEPH)+CT(W-PAN P)+TUBE/MASTER Green X 12 (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X 12 is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector.
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016401844 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green X 12 - 08800016401837

PHT-75CHS(SP12X8.5)(US)/P(W-PAN P)+CT(W-PAN P)+TUBE/MASTER Green X 12 (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X 12 is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector.
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016401837 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green X 18 - 08800016400793

Dental Computed Tomography X-ray System functioning Pano/CT/CEPH Image Acquisition Xmaru1524CF Master Plus OP, Xmaru2602CF/W-Ceph(P)/MASTER
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016400793 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green X 18 - 08800016400786

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xmaru1524CF Master Plus OP
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016400786 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Med X Change - 00817613020109

Foot Pedal - Med X Change Brand
Nds Surgical Imaging LLC
DRS030
Not in Commercial Distribution

  • 00817613020109 ()


  • Foot-switch, electrical

Polaris X™ - 08714729270188

Unidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0047005D0
In Commercial Distribution

  • 08714729270188 ()

  • 10 mm Length
  • 2 mm Length
  • 6 F Diameter
  • 2.00 mm Diameter


  • Cardiac mapping catheter, percutaneous, single-use

Polaris X™ - 08714729270171

Unidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0047004D0
In Commercial Distribution

  • 08714729270171 ()

  • 2 mm Length
  • 8 mm Length
  • 6 F Diameter
  • 2.00 mm Diameter


  • Cardiac mapping catheter, percutaneous, single-use

Polaris X™ - 08714729270164

Unidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0047003D0
In Commercial Distribution

  • 08714729270164 ()

  • 2.5 mm Length
  • 5 mm Length
  • 2.00 mm Diameter
  • 6 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
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