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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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Original Opaque
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059561 ()
  • D0019059540 ()
  • D0019060222 ()

  • Weight: 1000 Gram
905954

  • Dental appliance fabrication material, resin
Dark Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060212 ()
  • D0019059451 ()
  • D0019059350 ()

  • Weight: 1000 Gram
905935

  • Dental appliance fabrication material, resin
Light Reddish Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059441 ()
  • D0019059340 ()
  • D0019060202 ()

  • Weight: 1000 Gram
905934

  • Dental appliance fabrication material, resin
Light
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060192 ()
  • D0019059431 ()
  • D0019059330 ()

  • Weight: 1000 Gram
905933

  • Dental appliance fabrication material, resin
Original
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059421 ()
  • D0019059320 ()
  • D0019060182 ()

  • Weight: 1000 Gram
905932

  • Dental appliance fabrication material, resin
Micro Applicators Regular (2.00mm) Purple
Bright Supply, Inc.
BSI-1501
In Commercial Distribution

  • D974BSI20032 ()
  • D974BSI20031 ()
  • D974BSI20033 ()
  • D974BSI20030 ()


  • Dental material application tool, single-use
Locking Cap
Kalitec Direct LLC
11-LCL-0000
In Commercial Distribution

  • B07311LCL00000 ()
  • B07311LCL00002 ()
  • B07311LCL00001 ()


  • Spinal bone set screw
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-090
Not in Commercial Distribution

  • B090C140901 ()
  • B090C140900 ()
  • B090C140902 ()

  • Catheter Working Length: 90 Centimeter
  • Crossing Profile: 1.6 French
  • Catheter Gauge: 2 French
  • Introducer Sheath Compatibility: 2.9 French
C14-090

  • Vascular guide-catheter, single-use
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135
Not in Commercial Distribution

  • B090C351351 ()
  • B090C351350 ()
  • B090C351352 ()

  • Catheter Gauge: 3.9 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 3.2 French
  • Introducer Sheath Compatibility: 4 French
C35-135

  • Vascular guide-catheter, single-use
The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-175
Not in Commercial Distribution

  • B090C141751 ()
  • B090C141750 ()
  • B090C141752 ()

  • Catheter Gauge: 2 French
  • Introducer Sheath Compatibility: 2.9 French
  • Catheter Working Length: 175 Centimeter
  • Crossing Profile: 1.6 French
C14-175

  • Vascular guide-catheter, single-use
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