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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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SURGENTEC, LLC
SR16-6500
In Commercial Distribution

  • 00850040139334 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Hex Driver, 2.5mm
Voom Medical Devices, Inc
VDR01001
In Commercial Distribution

  • 00850041704111 ()

  • Outer Diameter: 2.5 Millimeter
VDR01001

  • Surgical screwdriver, reusable
Hex Driver, 2.0mm
Voom Medical Devices, Inc
VDR01000
In Commercial Distribution

  • 00850041704104 ()

  • Outer Diameter: 2 Millimeter
VDR01000

  • Surgical screwdriver, reusable
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
5.0 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006885 ()
1456-5050

  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Fluted surgical drill bit, single-use
  • Surgical instrument handle, non-torque-limiting
  • Surgical countersink, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
4.0 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006861 ()
1456-4040

  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
  • Fluted surgical drill bit, single-use
  • Surgical instrument handle, non-torque-limiting
  • Surgical countersink, single-use
  • Orthopaedic intraoperative positioning pin, single-use
VERTEK BUSHING FOR 2.4MM DRILL/DRIVER W/THUMBSCREW
PMT CORPORATION
2103-154
In Commercial Distribution

  • 00650551137580 ()


  • Neurological stereotactic surgery system
VERTEK BUSHING FOR 2.1MM DRILL/DRIVER W/THUMBSCREW
PMT CORPORATION
2103-153
In Commercial Distribution

  • 00650551137573 ()


  • Neurological stereotactic surgery system
PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has size #3-0 multifilament SS suture Each end of SS suture has pre-attached straight needles. Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
400-3031
In Commercial Distribution

  • 00859210006025 ()

  • Length: 4.5 Millimeter
  • Outer Diameter: 3 Millimeter
400-3031

  • Tendon/ligament bone anchor, non-bioabsorbable
The H&H Situational Instrument Tray (SIT) Kit is a sterile, single use kit for performing many surgical procedures immediately. The SIT Kit provides a generic set of must-have instruments in a convenient vacuum-sealed bag ready for use. The SIT kit contains: A 5.5" Straight Crile Hemostat A 4.5" Straight Iris Scissors A 9.75" Medium Magill Forceps A 6" Mayo-Hegar needle driver, and A protective sterile field wrap
H&H MEDICAL CORPORATION
1
In Commercial Distribution

  • 00857048006057 ()
HHSIT01

  • General surgical procedure kit, non-medicated, single-use
Pin Driver, Tri-flat, Hudson Connector
Orthalign, Inc.
403162
In Commercial Distribution

  • 00858704006954 ()
403162

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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