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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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TAPPER/DRIVER 2393002 TRAY
MEDTRONIC SOFAMOR DANEK, INC.
2393002
In Commercial Distribution

  • 00613994649508 ()


  • Instrument tray, reusable
COUNTER TORQUE 9010000153 ADJUSTABLE
MEDTRONIC SOFAMOR DANEK, INC.
9010000153
In Commercial Distribution

  • 00613994646057 ()


  • Surgical screwdriver, reusable
COUNTER TORQUE 9010000152 ADJUSTBL OPEN
MEDTRONIC SOFAMOR DANEK, INC.
9010000152
In Commercial Distribution

  • 00613994646040 ()


  • Surgical screwdriver, reusable
DRIVER 7578900 SET SCREW RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
7578900
In Commercial Distribution

  • 00613994644831 ()


  • Orthopaedic implant driver
DRIVER 5484111 4.75 LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
5484111
In Commercial Distribution

  • 00613994634054 ()


  • Surgical screwdriver, reusable
COUNTER TORQUE 8350395 STANDARD
MEDTRONIC SOFAMOR DANEK, INC.
8350395
In Commercial Distribution

  • 00613994538222 ()


  • Surgical screwdriver, reusable
DRIVER 8350392 T HAND SCREW ADJUSTMENT
MEDTRONIC SOFAMOR DANEK, INC.
8350392
In Commercial Distribution

  • 00613994538215 ()


  • Orthopaedic implant driver
SCREWDRIVER X0407373 TAPERED HEX
MEDTRONIC SOFAMOR DANEK, INC.
X0407373
In Commercial Distribution

  • 00613994504500 ()

  • DIA=3.5mm


  • Surgical screwdriver, reusable
COUNTER TORQUE X0408017 CLOSED
MEDTRONIC SOFAMOR DANEK, INC.
X0408017
In Commercial Distribution

  • 00613994504487 ()


  • Surgical screwdriver, reusable
INSTRUMENT 1209999 FLEX DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
1209999
In Commercial Distribution

  • 00613994504470 ()

  • Outer Diameter: 2.2 Millimeter


  • Orthopaedic implant driver
No Description
BIOMET 3I, LLC
GHX2.5DL
In Commercial Distribution

  • 00844868047117 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 30 Millimeter


  • Surgical screwdriver, reusable
No Description
BIOMET 3I, LLC
IXL1.2D
In Commercial Distribution

  • 00844868047100 ()

  • Outer Diameter: 1.2 Millimeter
  • Length: 30 Millimeter


  • Surgical screwdriver, reusable
TSV Angled Screw Channel Driver Tip 30MM
BIOMET 3I, LLC
TASCT30
In Commercial Distribution

  • 00844868044772 ()


  • Surgical screwdriver, reusable
TSV Angled Screw Channel Driver Tip 24MM
BIOMET 3I, LLC
TASCT24
In Commercial Distribution

  • 00844868044765 ()


  • Surgical screwdriver, reusable
TSV Angled Screw Channel Driver 30MM
BIOMET 3I, LLC
TASCD30
In Commercial Distribution

  • 00844868044758 ()


  • Surgical screwdriver, reusable
TSV Angled Screw Channel Driver 24MM
BIOMET 3I, LLC
TASCD24
In Commercial Distribution

  • 00844868044741 ()


  • Surgical screwdriver, reusable
ANGLED SCREW CHANNEL DRIVER TIP 30MM
BIOMET 3I, LLC
ASCDT30
In Commercial Distribution

  • 00844868044024 ()


  • Surgical screwdriver, reusable
ANGLED SCREW CHANNEL DRIVER TIP 24MM
BIOMET 3I, LLC
ASCDT24
In Commercial Distribution

  • 00844868044017 ()


  • Surgical screwdriver, reusable
ACCY 3550S-01 STIMLOC BURR-HOLE AIMD
MEDTRONIC, INC.
3550S-01
In Commercial Distribution

  • 00613994747204 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
CONTAINER 9734444 SOLERA TAPS DRIVERS
MEDTRONIC NAVIGATION, INC.
9734444
In Commercial Distribution

  • 00613994731388 ()


  • Device sterilization/disinfection container, reusable
CONTAINER 9734443 LEGACY TAPS DRIVERS
MEDTRONIC NAVIGATION, INC.
9734443
In Commercial Distribution

  • 00613994731371 ()


  • Device sterilization/disinfection container, reusable
DRIVER X0709479 REMOVAL
MEDTRONIC SOFAMOR DANEK, INC.
X0709479
In Commercial Distribution

  • 00613994723291 ()


  • Surgical drill guide, reusable
SCREWDRIVER X1009576 3.5 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X1009576
In Commercial Distribution

  • 00613994718129 ()


  • Surgical screwdriver, reusable
Bur Hole Groove Shunt Plate
OSTEOMED LLC
218-0069
In Commercial Distribution

  • 00845694016094 ()

  • Outer Diameter: 26 Millimeter
218-0069

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bur Hole Shunt Plate, Extended Hole
OSTEOMED LLC
218-0064
In Commercial Distribution

  • 00845694016087 ()

  • Outer Diameter: 30 Millimeter
218-0064

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Temporary Condyle Attachment (TCA)
OSTEOMED LLC
214-0300
In Commercial Distribution

  • 00845694015844 ()
214-0300

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mini, 68 Hole Strip, Low Profile
OSTEOMED LLC
210-1026
In Commercial Distribution

  • 00845694015837 ()

  • Length: 124 Millimeter
210-1026

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
13mm Segmental Rigid Plate
OSTEOMED LLC
210-0308
In Commercial Distribution

  • 00845694015820 ()

  • Span Length = 13mm
210-0308

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Extended (1.16") Driver Stem, OsteoDriverâ„¢
OSTEOMED LLC
450-0619
In Commercial Distribution

  • 00845694015738 ()
450-0619

  • Surgical screwdriver, reusable
1.6mm Low Profile, X-Large Bur Hole Plate
OSTEOMED LLC
218-0096
In Commercial Distribution

  • 00845694014953 ()

  • Outer Diameter: 31 Millimeter
218-0096

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