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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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TEMPORARY FIXATION SCREW INSTRUMENT, RIB, MAXDRIVE, TI-6AL-4V
KLS-Martin L.P.
24-015-64-71
In Commercial Distribution

  • 00888118131287 ()

  • 2.0 X 12 MM


  • Orthopaedic bone-fragment manipulator, single-use
Pressure Guidewire
BOSTON SCIENTIFIC CORPORATION
H7495551110
In Commercial Distribution

  • 08714729875758 ()

  • 185 cm Effective Length
  • 0.014 in Diameter


  • Intravascular haemodynamic monitoring system guidewire
Power Cord
BOSTON SCIENTIFIC CORPORATION
M0067912000
In Commercial Distribution

  • 08714729874690 ()


  • Electrical mains power extension cable
COMPEX EDGE 3.0
DJO, LLC
CX192WI03
In Commercial Distribution

  • 00190446337362 ()


  • Interferential electrical stimulation system
COMPEX PERFORMANCE 3.0
DJO, LLC
CX192WI02
In Commercial Distribution

  • 00190446337355 ()


  • Interferential electrical stimulation system
COMPEX SPORT ELITE 3.0
DJO, LLC
CX192WI01
In Commercial Distribution

  • 00190446337348 ()


  • Interferential electrical stimulation system
ROTATION TAMP
HYHTE HOLDINGS, INC.
LZA050000
In Commercial Distribution

  • 00840085233517 ()
LZA050000

  • Surgical tamp, reusable
STRAIGHT TAMP
HYHTE HOLDINGS, INC.
LZA040000
In Commercial Distribution

  • 00840085233500 ()
LZA040000

  • Surgical tamp, reusable
The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A / B Test.
MESA BIOTECH, INC.
FAB1100CW-C
In Commercial Distribution

  • B540FAB1100CWC0 ()
FAB1100CW-1

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
MESA BIOTECH, INC.
D2001
In Commercial Distribution

  • B540D20010 ()
D2001

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
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