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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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ICON, 4x12 Hole Reconstruction Plate, Locking, Left, 2.8mm Thick
OSTEOMED LLC
231-2811
In Commercial Distribution

  • 00845694056878 ()

  • Thickness = 2.8mm
231-2811

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ICON, 18 Hole Reconstruction Plate, Locking, 2.8mm Thick
OSTEOMED LLC
231-2802
In Commercial Distribution

  • 00845694056861 ()

  • Thickness = 2.8mm
231-2802

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ICON, 15 Hole Communition Plate, 2.0mm Thick
OSTEOMED LLC
231-2051
In Commercial Distribution

  • 00845694056854 ()

  • Thickness = 2.0mm
231-2051

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ICON, 6 Hole Fracture Plate, Locking, Long, 1.5mm Thick
OSTEOMED LLC
231-1513
In Commercial Distribution

  • 00845694056847 ()

  • Length: 52 Millimeter
231-1513

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ICON, 14 Hole Reconstruction Plate, Locking, 2.8mm Thick
OSTEOMED LLC
231-2801
In Commercial Distribution

  • 00845694056830 ()

  • Thickness = 2.8mm
231-2801

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ICON, 4 Hole Fracture Plate, Locking, Long, 1.5mm Thick
OSTEOMED LLC
231-1503
In Commercial Distribution

  • 00845694056144 ()

  • Length: 37 Millimeter
231-1503

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ICON, 4 Hole BSSO Plate, Locking, Short, 1.0mm Thick
OSTEOMED LLC
231-1000
In Commercial Distribution

  • 00845694055925 ()

  • Length: 26 Millimeter
231-1000

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile Zero, 35mm Gap Plate, Preformed
OSTEOMED LLC
218-0220
In Commercial Distribution

  • 00845694053266 ()

  • Length: 40 Millimeter
218-0220

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile Zero, 25mm Gap Plate, Preformed
OSTEOMED LLC
218-0219
In Commercial Distribution

  • 00845694053259 ()

  • Length: 29 Millimeter
218-0219

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
2.0mm Angled Locking L Plate, 6x3 Hole, Right
OSTEOMED LLC
213-1635
In Commercial Distribution

  • 00845694053198 ()

  • Length: 28 Millimeter
213-1635

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
2.0mm Driver Stem, Long, Hex Shank
OSTEOMED LLC
114-2033
In Commercial Distribution

  • 00845694052252 ()

  • Length: 3.25 Inch
114-2033

  • General internal orthopaedic fixation system implantation kit
2.0mm Driver Stem, Medium, Hex Shank
OSTEOMED LLC
114-2021
In Commercial Distribution

  • 00845694052245 ()

  • Length: 2.08 Inch
114-2021

  • General internal orthopaedic fixation system implantation kit
2.0mm Driver Stem, Short, Hex Shank
OSTEOMED LLC
114-2015
In Commercial Distribution

  • 00845694052238 ()

  • Length: 1.46 Inch
114-2015

  • General internal orthopaedic fixation system implantation kit
1.6mm Driver Stem, Long, Hex Shank
OSTEOMED LLC
114-1633
In Commercial Distribution

  • 00845694052221 ()

  • Length: 3.25 Inch
114-1633

  • General internal orthopaedic fixation system implantation kit
1.2mm Driver Stem, Long, Hex Shank
OSTEOMED LLC
114-1233
In Commercial Distribution

  • 00845694052214 ()

  • Length: 3.25 Inch
114-1233

  • General internal orthopaedic fixation system implantation kit
Screw Driver Sleeve
OSTEOMED LLC
320-2720
In Commercial Distribution

  • 00845694049412 ()
320-2720

  • General internal orthopaedic fixation system implantation kit
T15 Cannulated Screw Driver, Quick Release
OSTEOMED LLC
320-2615
In Commercial Distribution

  • 00845694049382 ()
320-2615

  • General internal orthopaedic fixation system implantation kit
T15 Screw Driver, Quick Release
OSTEOMED LLC
320-2400
In Commercial Distribution

  • 00845694049375 ()
320-2400

  • General internal orthopaedic fixation system implantation kit
2.0mm 5 Hole Offset Curved Lozenge Reduction Plate
OSTEOMED LLC
214-0116
In Commercial Distribution

  • 00845694049283 ()

  • Length: 41 Millimeter
214-0116

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DRIVER EX0610298 GENERAL SS MPA
MEDTRONIC SOFAMOR DANEK, INC.
EX0610298
In Commercial Distribution

  • 00613994840141 ()


  • Orthopaedic implant driver
DRIVER EX0610183 3.5MM CAPTIVE TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0610183
In Commercial Distribution

  • 00613994839138 ()


  • Orthopaedic implant driver
DRIVER EX0411334 6.35 PROV. T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0411334
In Commercial Distribution

  • 00613994997487 ()


  • Orthopaedic implant driver
HEX DRIVER, 3.5mm
Pioneer Surgical Technology, Inc.
405-696
Not in Commercial Distribution

  • 00846468041045 ()
405-696

  • General internal orthopaedic fixation system implantation kit
Torque Driver
Pioneer Surgical Technology, Inc.
400-908
Not in Commercial Distribution

  • 00846468040932 ()


  • Internal spinal fixation system cable
CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9906.0014.11S
In Commercial Distribution

  • 04717002404335 ()
  • 14717002404332 ()
  • 24717002404339 ()
9906.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9905.0014.11S
In Commercial Distribution

  • 14717002404325 ()
  • 04717002404328 ()
  • 24717002404322 ()
9905.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
5mm Hex Set Screw Driver(self-retaining)
BAUI BIOTECH CO. LTD.
409-0829
In Commercial Distribution

  • 04715862873629 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Poly Axial Screw Driver
BAUI BIOTECH CO. LTD.
409-0824
In Commercial Distribution

  • 04715862873575 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Mono Axial Screw Driver
BAUI BIOTECH CO. LTD.
409-0823
In Commercial Distribution

  • 04715862873568 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Poly Axial Screw Adjustable Driver
BAUI BIOTECH CO. LTD.
409-0813
In Commercial Distribution

  • 04715862873537 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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