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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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TrackX - 00857088008080

The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
TrackX Technology, LLC
VISION™-V SNAP
In Commercial Distribution

  • 00857088008097 ()
  • 00857088008080 ()
TX-3-3109

  • Diagnostic x-ray digital imaging system workstation application software

TrackX - 00857088008042

Disposable snap that snaps onto a Jamshidi for the purpose of instrument tracking. Component body part # TX-3-3203
TrackX Technology, LLC
VISION-T SNAP
In Commercial Distribution

  • 00857088008066 ()
  • 00857088008042 ()
  • 00857088008059 ()
TX-3-3108

  • Diagnostic x-ray digital imaging system workstation application software

Ultra ICE Plus - 08714729904380

IntraCardiac Echo Catheter
BOSTON SCIENTIFIC CORPORATION
M00499120
In Commercial Distribution

  • 08714729904380 ()

  • 110 cm Effective Length
  • 2.82 mm Diameter
  • 8.5 F Diameter


  • Cardiovascular ultrasound imaging system

Ultra ICE Plus - 08714729904373

IntraCardiac Echo Catheter
BOSTON SCIENTIFIC CORPORATION
M00499100
In Commercial Distribution

  • 08714729904373 ()

  • 2.82 mm Diameter
  • 8.5 F Diameter
  • 110 cm Effective Length


  • Cardiovascular ultrasound imaging system

NA - 08714729228684

Disposable Pullback Sled for Motordrive
BOSTON SCIENTIFIC CORPORATION
H749A70200
In Commercial Distribution

  • 08714729228684 ()


  • Cardiovascular ultrasound imaging system

Bolt Navigation - BN981BN002023

Bolt Navigation Case
Circinus Medical Technology LLC
BN002-02
In Commercial Distribution

  • BN981BN002023 ()
BN002-02

  • Surgical planning/navigation-enhancement system

Bolt Navigation - B981BN00201103

Bolt Navigation Sterile Case used with the Bolt Navigation System
Circinus Medical Technology LLC
BN002-01-10
In Commercial Distribution

  • B981BN00201101 ()
  • B981BN00201103 ()
BN002-01-10

  • Surgical planning/navigation-enhancement system

Treatment Pack (Type KP) - 04049471110166

single use accessory for ZEISS femtosecond lasers
Carl Zeiss Meditec AG
1016
In Commercial Distribution

  • 04049471100167 ()
  • 04049471110166 ()


  • Femtosecond ophthalmic solid-state laser system

Treatment Pack (Size L) - 04049471110159

single use accessory for ZEISS femtosecond lasers
Carl Zeiss Meditec AG
1015
In Commercial Distribution

  • 04049471100150 ()
  • 04049471110159 ()


  • Femtosecond ophthalmic solid-state laser system

Treatment Pack (Size M) - 04049471110142

single use accessory for ZEISS femtosecond lasers
Carl Zeiss Meditec AG
1014
In Commercial Distribution

  • 04049471100143 ()
  • 04049471110142 ()


  • Femtosecond ophthalmic solid-state laser system
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