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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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Cannulated Drill with Shoulder
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GLC4630 ()
GLC463

  • Bone-screw internal spinal fixation system, non-sterile
Distractor with Serrated Handles
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL4170 ()
GL417

  • Bone-screw internal spinal fixation system, non-sterile
Compressor with Serrated Handles
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL4160 ()
GL416

  • Bone-screw internal spinal fixation system, non-sterile
TI COLLAR WITH GROOVES
Synthes GmbH
498.011
In Commercial Distribution

  • H9814980110 ()
  • 10705034788593 ()
498011

  • Spinal bone set screw
Freer Elevator with Suction
Mytamed, Inc.
7.35.07
Not in Commercial Distribution

  • B351735070 ()
7.35.07

  • Periosteal elevator, reusable
Fiber Optic Retractor With Suction, 1 Inch X 6 Inch Blade With Right Angle Tip With Teeth, Autoclavable Non-
Surgical Direct, Inc.
SD12343-FST
In Commercial Distribution

  • B382SD12343FST0 ()
SD12343-FST

  • Fibreoptic retractor handle
MedentiBASE titanium base
MEDENTiKA GmbH
NNC 4840-ET
In Commercial Distribution

  • EMKANNC4840ET9 ()
  • 04251574839756 ()

  • compatible with Bredent Medical / SKY®*
NNC 4840-ET

  • Dental implant suprastructure, permanent, preformed
MedentiBASE titanium base
MEDENTiKA GmbH
I 4840-ET
In Commercial Distribution

  • EMKAI4840ET9 ()
  • 04251574839367 ()

  • compatible with BIOMET 3i / External Hex
I 4840-ET

  • Dental implant suprastructure, permanent, preformed
Multi-unit titanium base
MEDENTiKA GmbH
H 8508-ET
In Commercial Distribution

  • EMKAH8508ET9 ()
  • 04251574839299 ()

  • compatible with BIOMET 3i / Certain®*
H 8508-ET

  • Dental implant suprastructure, permanent, preformed
MedentiBASE titanium base
MEDENTiKA GmbH
H 4840-ET
In Commercial Distribution

  • EMKAH4840ET9 ()
  • 04251574839244 ()

  • compatible with BIOMET 3i / Certain®*
H 4840-ET

  • Dental implant suprastructure, permanent, preformed
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