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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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FlexDex Surgical
FD-335 ND
Not in Commercial Distribution

  • 00860004002116 ()
  • 00860004002109 ()


  • Suturing needle holder, single-use
Pump Driver Service Replacement Kit
Breethe, Inc.
001-0301-003
In Commercial Distribution

  • 00860001797947 ()
001-0301-003

  • Cardiopulmonary bypass system, non-roller type
SAM IO Driver
ZIEN MEDICAL TECHNOLOGIES, INC.
IO700
In Commercial Distribution

  • 10850068519030 ()
  • 00850068519033 ()


  • Intraosseous-access handpiece, infusion, manual
FORWARD IO Infusion Kit with SAM IO Adaptor, SAM IO Driver, SAM IO 25mm Needle Assembly and SAM IO 45mm Assembly.
INTEGRATED MEDCRAFT LLC
1011-23000CB
In Commercial Distribution

  • 00850056748018 ()


  • Intraosseous infusion kit
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
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
TRAUMA KIT, 1211-1S SMALL SHORT RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, (2) 1201-43 3" SKULL PINS, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6SS1
In Commercial Distribution

  • 00650551003861 ()


  • Cervical spine immobilization system, single-use
Pneumatic Footswitch
Buffalo Filter
FS10004
Not in Commercial Distribution

  • 00851136002969 ()


  • Foot-switch, pneumatic
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