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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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QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX
TEDAN SURGICAL INNOVATIONS, L.L.C.
DS-0024
In Commercial Distribution

  • 10851797006488 ()
  • 00851797006481 ()

  • Length: 14 Millimeter


  • Spinal intraoperative positioning pin, single-use
QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX
TEDAN SURGICAL INNOVATIONS, L.L.C.
DS-0022
In Commercial Distribution

  • 10851797006471 ()
  • 00851797006474 ()

  • Length: 12 Millimeter


  • Spinal intraoperative positioning pin, single-use
DISTRACTION SCREW, 16 MM, STERILE, 5/BOX
TEDAN SURGICAL INNOVATIONS, L.L.C.
DS-0016
In Commercial Distribution

  • 10851797006464 ()
  • 00851797006467 ()

  • Length: 16 Millimeter


  • Spinal intraoperative positioning pin, single-use
DISTRACTION SCREW, 14 MM, STERILE, 5/BOX
TEDAN SURGICAL INNOVATIONS, L.L.C.
DS-0014
In Commercial Distribution

  • 10851797006457 ()
  • 00851797006450 ()

  • Length: 14 Millimeter


  • Spinal intraoperative positioning pin, single-use
DISTRACTION SCREW, 12 MM, STERILE, 5/BOX
TEDAN SURGICAL INNOVATIONS, L.L.C.
DS-0012
In Commercial Distribution

  • 10851797006440 ()
  • 00851797006443 ()

  • Length: 12 Millimeter


  • Spinal intraoperative positioning pin, single-use
The instrument tray (Gold) is optional and may be used for storage and transportation of On-X® Heart Valve instruments. The tray can withstand steam sterilization and instruments may be sterilized in this tray.
ON-X LIFE TECHNOLOGIES, INC.
ONXI3-CT
In Commercial Distribution

  • 00851788001747 ()
ONXI3-CT

  • Instrument tray, reusable
The instrument tray (Grey) is optional and may be used for storage and transportation of On-X® Heart Valve instruments. The tray can withstand steam sterilization and the instruments may be sterilized in this tray.
ON-X LIFE TECHNOLOGIES, INC.
ONXI2-CT
In Commercial Distribution

  • 00851788001174 ()
ONXI2-CT

  • Instrument tray, reusable
Instrument Handle – all sizes. The instrument handle facilitates holding the valve or the rotator during surgery. The instrument handle is comprised of a grip, a bendable stem and a tip.
ON-X LIFE TECHNOLOGIES, INC.
ONXI2-H
In Commercial Distribution

  • 00851788001150 ()
ONXI2-H

  • Heart valve prosthesis sizer handle
No Description
JACE MEDICAL, LLC
215.010.15
In Commercial Distribution

  • 00851599007914 ()


  • Surgical screwdriver, reusable
No Description
JACE MEDICAL, LLC
201.050.00
Not in Commercial Distribution

  • 00851599007679 ()


  • Surgical screwdriver, reusable
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