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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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Alert Display Driver (ADD) - Configuration 2 (curved)
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-2
Not in Commercial Distribution

  • 00850016398024 ()
D-ADD-X-2

  • Nurse call system
Alert Display Driver (ADD) - Configuration 1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-1
Not in Commercial Distribution

  • 00850016398017 ()
D-ADD-X-1

  • Nurse call system
Midface Reconstruction kit
Materialise NV
SD980.032
In Commercial Distribution

  • 05420060380761 ()
SD980.032

  • Custom-made organ/bone anatomy model/surgical guide kit
Mandible Reconstruction kit
Materialise NV
SD980.031
In Commercial Distribution

  • 05420060380754 ()
SD980.031

  • Custom-made organ/bone anatomy model/surgical guide kit
Titanium 3D Printed Guide, Bone harvesting
Materialise NV
SD980.028
In Commercial Distribution

  • 05420060380747 ()
SD980.028

  • Custom-made orthopaedic/craniofacial surgical guide
ATHERECTOMY H1-14550 CUTTER DRIVER V03
Covidien LP
H1-14550
In Commercial Distribution

  • 00643169777644 ()


  • Mechanical atherectomy system catheter, peripheral
ATT MR8 MR8-AD02 DRIVER JACOBS CHK 5/32
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-AD02
In Commercial Distribution

  • 00643169912724 ()


  • Burring power tool attachment
ATT MR8-AD03 MR8 PERF DRIVER 1000RPM
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-AD03
In Commercial Distribution

  • 00643169912717 ()


  • Burring power tool attachment
Screw, 5mm, Burr Hole Cover
ST. JUDE MEDICAL, INC.
6015
In Commercial Distribution

  • 15415067030297 ()
  • 05415067030290 ()
6015

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Cranial Burr Hole Cover Sys.
ST. JUDE MEDICAL, INC.
6010
In Commercial Distribution

  • 05415067030283 ()
6010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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