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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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Double Buttress Plate Screw Driver
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP1040 ()
GBP104

  • Bone-screw internal spinal fixation system, non-sterile
Buttress Plate Screw Driver
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP1020 ()
GBP102

  • Bone-screw internal spinal fixation system, non-sterile
K-wire 45mm screw Standard Driver
Intelivation, LLC
C50-8000-022
In Commercial Distribution

  • G079C5080000220 ()


  • Orthopaedic bone pin, non-bioabsorbable
Power Driver
SPINEOLOGY INC.
86-05-47
In Commercial Distribution

  • M7408600547 ()
860-0547

  • Metallic spinal interbody fusion cage
Manual Driver
SPINEOLOGY INC.
86-05-46
In Commercial Distribution

  • M7408600546 ()
860-0546

  • Metallic spinal interbody fusion cage
Inserter Driver
Xtant Medical Holdings, Inc.
T092-0450
Not in Commercial Distribution

  • M697T09204500 ()
  • M697T09204501 ()


  • Metallic spinal interbody fusion cage
7 1/2" Combination Mallet, Aluminum Handle, Stainless Steel Head 8 oz and One Nylon Cap
Surgical Direct, Inc.
SD9145693-1001
In Commercial Distribution

  • B382SD914569310010 ()
SD9145693-1001

  • Surgical mallet
7 1/2" Heath Mallet, 2lbs
Surgical Direct, Inc.
SD914556109
In Commercial Distribution

  • B382SD9145561090 ()
SD914556109

  • Surgical mallet
9 1/2" Bergman Mallet, 10.5oz
Surgical Direct, Inc.
SD91451831
In Commercial Distribution

  • B382SD914518310 ()
SD91451831

  • Surgical mallet
FN AR Driver Bolt
Flow-FX
101-54
In Commercial Distribution

  • B267101540 ()
101-54

  • Orthopaedic bone bolt
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