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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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Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000953 ()
Reconstruction Planner

  • CAD/CAM software
Materialise Mimics Enlight CMF Orthognathic and Trauma Planner
Materialise NV
Orthognathic and Trauma Planner
In Commercial Distribution

  • 05404028000946 ()
Orthognathic and Trauma Planner

  • CAD/CAM software
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000816 ()
Reconstruction Planner

  • CAD/CAM software
Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software
Laparoscopy wound closure system pack consists of: 05391529640439; neoClose Anchor (Long Driver) x 2 US; Model Number NCAALX2-U
NEOSURGICAL LIMITED
NCAALX2-U
In Commercial Distribution

  • 05391529640569 ()
  • 05391529640552 ()
  • 05391529640439 ()


  • Laparoscopic wound closure thread
ACCY KIT 355015 BURR HOLE RNG W/CAP FWU
MEDTRONIC, INC.
355015
Not in Commercial Distribution

  • 00643169887473 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
SAFIRA System hand operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Palm Operator
In Commercial Distribution

  • 05060727270068 ()
900059

  • Pain management medication delivery system
SAFIRA Driver unit that injects/aspirates works in combination with SAFIRA operators and SAFIRA Syringes
MEDOVATE LIMITED
SAFIRA Driver
In Commercial Distribution

  • 05060727270020 ()
900029

  • Pain management medication delivery system
SAFIRA system foot operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Foot Pedal
In Commercial Distribution

  • 05060727270013 ()
900044

  • Pain management medication delivery system
Instrument, Allen Key for 0.9mm Hex
SOUTHERN IMPLANTS (PTY) LTD
I-KEY-09
In Commercial Distribution

  • 06009544012139 ()


  • Surgical screwdriver, reusable
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