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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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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
Ear Loop Surgical Face Mask, Pink, Non-Sterile
Uniseal
711-2P
In Commercial Distribution

  • 30744514711243 ()
  • 20744514711246 ()
  • 10744514711249 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
SHARP™ Heavy-Body Premium Hydrophilic VPS Impression Material
PARKELL, INC.
S512
Not in Commercial Distribution

  • M595S5121 ()
  • M595S5120 ()
S512

  • Silicone dental impression material
SHARP™ Medium Body Premium Hydrophilic VPS Impression Material
PARKELL, INC.
S511
Not in Commercial Distribution

  • M595S5111 ()
  • M595S5110 ()
S511

  • Silicone dental impression material
SHARP™ Wash Premium Hydrophilic VPS Impression Material
PARKELL, INC.
S510
Not in Commercial Distribution

  • M595S5101 ()
  • M595S5100 ()
S510

  • Silicone dental impression material
Quick Cinch™ Heavy Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S463S
Not in Commercial Distribution

  • M595S463S1 ()
  • M595S463S0 ()
S463S

  • Silicone dental impression material
Quick Cinch™ Light-Body in Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S461S
Not in Commercial Distribution

  • M595S461S1 ()
  • M595S461S0 ()
S461S

  • Silicone dental impression material
Cinch™ Light Split-Cartridge System (4-Cartridges & Mixing Tips)
PARKELL, INC.
S460S
Not in Commercial Distribution

  • M595S460S1 ()
  • M595S460S0 ()
S460S

  • Silicone dental impression material
Super-Fast Blu-Mousse® Split-Cartridge System
PARKELL, INC.
S457S
Not in Commercial Distribution

  • M595S457S1 ()
  • M595S457S0 ()
S457S

  • Silicone dental impression material
Super-Fast Blu-Mousse® Standard-Cartridge System
PARKELL, INC.
S457
Not in Commercial Distribution

  • M595S4571 ()
  • M595S4570 ()
S457

  • Silicone dental impression material
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