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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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MALLET
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300031
In Commercial Distribution

  • 00850073363270 ()


  • Surgical mallet
SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300017
In Commercial Distribution

  • 00850073363218 ()


  • Surgical screwdriver, reusable
No Description
Wheelhouse Medical
WM01-0112
In Commercial Distribution

  • 00850058050102 ()


  • Surgical screwdriver, reusable
No Description
Wheelhouse Medical
WM01-0086
In Commercial Distribution

  • 00850058050072 ()


  • Surgical screwdriver, reusable
DriverClip NBM. Clip recess underside of finger dental implant screwdriver with floss tether attachment. Resilient slide lock. Single use.
Implantwise LLC
NBM.
In Commercial Distribution

  • 00850043387367 ()


  • Surgical instrument interim-placement holder, single-use
DriverClip S. Clip recess underside of finger dental implant screwdriver with floss tether attachment. Single use only.
Implantwise LLC
S
In Commercial Distribution

  • 00850043387350 ()


  • Surgical instrument interim-placement holder, single-use
DriverClip Universal. Clip that goes through any orifice of a dental implant screwdriver with a floss tether attachment. Single use only.
Implantwise LLC
Universal
In Commercial Distribution

  • 00850043387343 ()


  • Surgical instrument interim-placement holder, single-use
Driver, T6 Torx X15TN SS
Accufix Surgical, Inc.
AJDH-T6-X15TN
In Commercial Distribution

  • 00850044114009 ()
AJDH-T6-X15TN

  • Surgical screwdriver, reusable
The MotoBAND™ CP DynaForce® MPJ Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws. Certain plates in the system are compatible with the MotoCLIP/DynaForce Superelastic Fixation System.
CROSSROADS EXTREMITY SYSTEMS
1500-4801
In Commercial Distribution

  • 00850038154189 ()
1500-4801

  • Surgical screwdriver, single-use
  • Surgical screwdriver, reusable
  • Orthopaedic prosthesis implantation positioning instrument, 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
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
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