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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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Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution

  • B08810310 ()
  • B08810317 ()
  • B08810313 ()
21-031-001

  • Differential/selective broth culture medium IVD
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
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.
C14-135
Not in Commercial Distribution

  • B090C141351 ()
  • B090C141350 ()
  • B090C141352 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-135

  • Vascular guide-catheter, single-use
Micro Applicators Regular (2.00mm) Purple
Bright Supply, Inc.
BSI-1501
In Commercial Distribution

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


  • Dental material application tool, 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.
C14-090
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
8001 Series Foley Catheter Temperature Probe, 16 FR
MEASUREMENT SPECIALTIES, INC.
8001-063-416
In Commercial Distribution

  • H29780010634160 ()
  • H29780010634161 ()
  • H29780010634162 ()

  • Catheter Gauge: 16 French
8001-063-416

  • General-purpose patient temperature probe, single-use
8001 Series Foley Catheter Temperature Probe, 14 FR
MEASUREMENT SPECIALTIES, INC.
8001-063-414
In Commercial Distribution

  • H29780010634142 ()
  • H29780010634141 ()
  • H29780010634140 ()

  • Catheter Gauge: 14 French
8001-063-414

  • General-purpose patient temperature probe, single-use
Foley Catheter Temperature Probe, 18 FR
MEASUREMENT SPECIALTIES, INC.
4468
In Commercial Distribution

  • H29744682 ()
  • H29744681 ()
  • H29744680 ()

  • Catheter Gauge: 18 French
861557

  • General-purpose patient temperature probe, single-use
Foley Catheter Temperature Probe, 16 FR
MEASUREMENT SPECIALTIES, INC.
4466
In Commercial Distribution

  • H29744660 ()
  • H29744661 ()
  • H29744662 ()

  • Catheter Gauge: 16 French
861556

  • General-purpose patient temperature probe, single-use
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