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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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Bur Hole Plate, Small
OSTEOMED LLC
218-0067
In Commercial Distribution

  • 00845694091008 ()

  • Length: 16.22 Millimeter
218-0067

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Bur Hole Plate, Medium
OSTEOMED LLC
218-0066
In Commercial Distribution

  • 00845694090995 ()

  • Outer Diameter: 21.92 Millimeter
218-0066

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
X Plate, Xsmall
OSTEOMED LLC
218-0065
In Commercial Distribution

  • 00845694090988 ()

  • Outer Diameter: 14.35 Millimeter
218-0065

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile Zero Suboccipital Plate
OSTEOMED LLC
218-0227
In Commercial Distribution

  • 00845694090759 ()

  • Length: 94 Millimeter
218-0227

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile Zero Retrosigmoid Plate
OSTEOMED LLC
218-0226
In Commercial Distribution

  • 00845694090742 ()

  • Length: 56 Millimeter
218-0226

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile Zero Translabyrinthine Plate
OSTEOMED LLC
218-0225
In Commercial Distribution

  • 00845694090735 ()

  • Length: 73 Millimeter
218-0225

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile Zero MVD Plate
OSTEOMED LLC
218-0224
In Commercial Distribution

  • 00845694090728 ()

  • Length: 39 Millimeter
218-0224

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile Zero Temporal Plate
OSTEOMED LLC
218-0223
In Commercial Distribution

  • 00845694090711 ()

  • Length: 91 Millimeter
218-0223

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 Shunt Plate, Wide Groove
OSTEOMED LLC
218-0228
In Commercial Distribution

  • 00845694089098 ()

  • Outer Diameter: 27 Millimeter
218-0228

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6mm Driver Stem, Hex SPD, Short
OSTEOMED LLC
220-0217
In Commercial Distribution

  • 00845694089081 ()

  • Length: 1.71 Inch
220-0217

  • General internal orthopaedic fixation system implantation kit
SCREWDRIVER 9734374 G4 PEEK REDUCTION
MEDTRONIC NAVIGATION, INC.
9734374
In Commercial Distribution

  • 00613994771230 ()


  • Surgical screwdriver, reusable
SCREWDRIVER 9734373 SOLERA REDUCTION
MEDTRONIC NAVIGATION, INC.
9734373
In Commercial Distribution

  • 00613994771223 ()


  • Surgical screwdriver, reusable
SCREWDRIVER 9734279 SOLERA STANDARD
MEDTRONIC NAVIGATION, INC.
9734279
In Commercial Distribution

  • 00613994771216 ()


  • Surgical screwdriver, reusable
SCREWDRIVER 9734275 LGY G4 REDUCTION
MEDTRONIC NAVIGATION, INC.
9734275
In Commercial Distribution

  • 00613994771193 ()


  • Surgical screwdriver, reusable
Universal screw driver, T20
UNITED ORTHOPEDIC CORP.
9208-1103
In Commercial Distribution

  • 04719872142591 ()
9208-1103

  • Surgical screwdriver, reusable
Screw driver, T20
UNITED ORTHOPEDIC CORP.
9208-1102
In Commercial Distribution

  • 04719872142584 ()
9208-1102

  • Surgical screwdriver, reusable
Driver handle, 3/8" SQ
UNITED ORTHOPEDIC CORP.
9415-1302
In Commercial Distribution

  • 04719872140177 ()


  • Surgical instrument handle, non-torque-limiting
USTAR II Stem trial driver
UNITED ORTHOPEDIC CORP.
9315-1102
In Commercial Distribution

  • 04719872140160 ()


  • Surgical instrument handle, non-torque-limiting
A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention.
ENTER MEDICAL CORPORATION
PN-2002
In Commercial Distribution

  • 04719872108795 ()


  • Mouth gag, non-adjustable
Cup impactor driver
UNITED ORTHOPEDIC CORP.
9206-1118
In Commercial Distribution

  • 04719872141525 ()


  • Surgical screwdriver, reusable
DRIVER, SET SCREW
Pioneer Surgical Technology, Inc.
23-SETSCREWINS
Not in Commercial Distribution

  • 00846468027490 ()


  • General internal orthopaedic fixation system implantation kit
NUT DRIVER
Pioneer Surgical Technology, Inc.
23-NUTDRIVER
Not in Commercial Distribution

  • 00846468027391 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
21-TORQ-HANDLE
Not in Commercial Distribution

  • 00846468025960 ()


  • General internal orthopaedic fixation system implantation kit
CROSSLINK FINAL DRIVER
Xtant Medical Holdings, Inc.
02-XLNK-FLDRIVER
Not in Commercial Distribution

  • 00846468006372 ()
02-XLNK-FLDRIVER

  • General internal orthopaedic fixation system implantation kit
Final Driver, Extended
Pioneer Surgical Technology, Inc.
21-EXTDFINALDRV-TL
Not in Commercial Distribution

21-EXTDFINALDRV-TL

  • Orthopaedic inorganic implant inserter/extractor, reusable
SCREW DRIVER, BONE SCREW
Pioneer Surgical Technology, Inc.
21-DRIVER-TF
Not in Commercial Distribution

21-DRIVER-TF

  • Surgical screwdriver, reusable
SCREW DRIVER, BONE SCREW
Pioneer Surgical Technology, Inc.
21-DRIVER
Not in Commercial Distribution

21-DRIVER

  • Surgical screwdriver, reusable
Driver
Pioneer Surgical Technology, Inc.
83-DRIVER
Not in Commercial Distribution

83-DRIVER

  • Orthopaedic counter-torque/rod-pushing instrument
DRIVER, X-LINK
Pioneer Surgical Technology, Inc.
10-XLINKDRIVER
Not in Commercial Distribution

10-XLINKDRIVER

  • General internal orthopaedic fixation system implantation kit
Cup positioner, offset
UNITED ORTHOPEDIC CORP.
9207-1303
In Commercial Distribution

  • 04719872143246 ()
9207-1303

  • Orthopaedic inorganic implant inserter/extractor, reusable
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