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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No Description
Osstem Implant Co., Ltd.
OTWLDS
In Commercial Distribution

  • 08809917070951 ()


  • Surgical screwdriver, reusable
No Description
Osstem Implant Co., Ltd.
OTWLDL
In Commercial Distribution

  • 08809917070944 ()


  • Surgical screwdriver, reusable
No Description
Osstem Implant Co., Ltd.
OBSCHDT
In Commercial Distribution

  • 08809917070487 ()


  • Surgical screwdriver, reusable
No Description
Osstem Implant Co., Ltd.
HOGMDW
In Commercial Distribution

  • 08809917070159 ()


  • Surgical screwdriver, reusable
No Description
Osstem Implant Co., Ltd.
HOGMDR
In Commercial Distribution

  • 08809917070142 ()


  • Surgical screwdriver, reusable
Profile Zero , XXL Burr Hole Plate
OSTEOMED LLC
218-0236
In Commercial Distribution

  • 00842528127162 ()

  • Outer Diameter: 1.6 Inch
218-0236

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Ø3.7mm Proximal Cortex Drill, Quick Release
OSTEOMED LLC
316-0543
In Commercial Distribution

  • 00842528126929 ()

  • Outer Diameter: 3.7 Millimeter
316-0543

  • Cannulated surgical drill bit, single-use, non-sterile
5x20x5 Hole Reconstruction Plate, Locking, 2.8mm Thick
OSTEOMED LLC
241-2807
In Commercial Distribution

  • 00842528126912 ()

  • Thickness = 2.8mm
241-2807

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
5x16x5 Hole Reconstruction Plate, Locking, 2.8mm Thick
OSTEOMED LLC
241-2806
In Commercial Distribution

  • 00842528126905 ()

  • Thickness = 2.8mm
241-2806

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
5x16 Hole Reconstruction Plate, Locking, Right, 2.8mm Thick
OSTEOMED LLC
241-2805
In Commercial Distribution

  • 00842528126899 ()

  • Thickness = 2.8mm
241-2805

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
5x16 Hole Reconstruction Plate, Locking, Left, 2.8mm Thick
OSTEOMED LLC
241-2804
In Commercial Distribution

  • 00842528126882 ()

  • Thickness = 2.8mm
241-2804

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
4x12 Hole Reconstruction Plate, Locking, Right, 2.8mm Thick
OSTEOMED LLC
241-2803
In Commercial Distribution

  • 00842528126875 ()

  • Thickness = 2.8mm
241-2803

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
4x12 Hole Reconstruction Plate, Locking, Left, 2.8mm Thick
OSTEOMED LLC
241-2802
In Commercial Distribution

  • 00842528126868 ()

  • Thickness = 2.8mm
241-2802

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
18 Hole Reconstruction Plate, Locking, 2.8mm Thick
OSTEOMED LLC
241-2801
In Commercial Distribution

  • 00842528126851 ()

  • Thickness = 2.8mm
241-2801

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Ø2.7mm Cannulated Drill, Quick Release
OSTEOMED LLC
316-0534
In Commercial Distribution

  • 00842528126738 ()

  • Outer Diameter: 2.7 Millimeter
316-0534

  • Cannulated surgical drill bit, single-use, non-sterile
Ø2.3mm Cannulated Drill, Quick Release
OSTEOMED LLC
316-0532
In Commercial Distribution

  • 00842528126707 ()

  • Outer Diameter: 2.3 Millimeter
316-0532

  • Cannulated surgical drill bit, single-use, non-sterile
1.5mm x 6” K-wire
OSTEOMED LLC
316-0516
In Commercial Distribution

  • 00842528126691 ()

  • Outer Diameter: 0.097 Inch
316-0516

  • Cannulated surgical drill bit, single-use
1.7mm Cannulated Drill, Long, Quick Release
OSTEOMED LLC
316-0514
In Commercial Distribution

  • 00842528126684 ()

  • Outer Diameter: 1.7 Millimeter
316-0514

  • Cannulated surgical drill bit, single-use, non-sterile
1.7mm Cannulated Drill, Short, Quick Release
OSTEOMED LLC
316-0513
In Commercial Distribution

  • 00842528126677 ()

  • Outer Diameter: 1.7 Millimeter
316-0513

  • Cannulated surgical drill bit, single-use, non-sterile
3.0/4.0mm T10 Driver, Cannulated, Long, Quick Release
OSTEOMED LLC
316-0555
In Commercial Distribution

  • 00842528126400 ()

  • Outer Diameter: 0.1072 Inch
316-0555

  • Surgical screwdriver, reusable
3.0/4.0mm T10 Driver, Cannulated, Short, Quick Release
OSTEOMED LLC
316-0554
In Commercial Distribution

  • 00842528126394 ()

  • Outer Diameter: 0.1072 Inch
316-0554

  • Surgical screwdriver, reusable
Ø3.2mm Proximal Cortex Drill, Quick Release
OSTEOMED LLC
316-0533
In Commercial Distribution

  • 00842528126387 ()

  • Outer Diameter: 0.126 Inch
316-0533

  • Cannulated surgical drill bit, single-use, non-sterile
2.0/2.4mm T7 Driver, Cannulated, Long, Quick Release
OSTEOMED LLC
316-0545
In Commercial Distribution

  • 00842528126370 ()

  • Outer Diameter: 0.079 Inch
316-0545

  • Surgical screwdriver, reusable
2.0/2.4mm T7 Driver, Cannulated, Short, Quick Release
OSTEOMED LLC
316-0544
In Commercial Distribution

  • 00842528126363 ()

  • Outer Diameter: 0.079 Inch
316-0544

  • Surgical screwdriver, reusable
203mm x 203mm Rigid OsteoForm Mesh
OSTEOMED LLC
218-4502
In Commercial Distribution

  • 00842528125786 ()

  • Length: 8 Inch
  • length of mesh
218-4502

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
150mm x 150mm Rigid OsteoForm Mesh
OSTEOMED LLC
218-4501
In Commercial Distribution

  • 00842528125779 ()

  • Length: 6.2 Inch
  • length of mesh
218-4501

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
124mm x 124mm Rigid OsteoForm Mesh
OSTEOMED LLC
218-4500
In Commercial Distribution

  • 00842528125762 ()

  • Length: 5.3 Inch
  • length of mesh
218-4500

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 7MM STP RT
OSTEOMED LLC
213-0185
In Commercial Distribution

  • 00842528125755 ()
213-0185

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 7MM STP LF
OSTEOMED LLC
213-0184
In Commercial Distribution

  • 00842528125748 ()
213-0184

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 5MM STP RT
OSTEOMED LLC
213-0183
In Commercial Distribution

  • 00842528125731 ()
213-0183

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 5MM STP LF
OSTEOMED LLC
213-0182
In Commercial Distribution

  • 00842528125724 ()
213-0182

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 3MM STP RT
OSTEOMED LLC
213-0181
In Commercial Distribution

  • 00842528125717 ()
213-0181

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 3MM STP LF
OSTEOMED LLC
213-0180
In Commercial Distribution

  • 00842528125700 ()
213-0180

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 10MM STP RT
OSTEOMED LLC
213-0157
In Commercial Distribution

  • 00842528125694 ()
213-0157

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 10MM STP LF
OSTEOMED LLC
213-0156
In Commercial Distribution

  • 00842528125687 ()
213-0156

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 8MM STP RT
OSTEOMED LLC
213-0155
In Commercial Distribution

  • 00842528125670 ()
213-0155

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 8MM STP LF
OSTEOMED LLC
213-0154
In Commercial Distribution

  • 00842528125663 ()
213-0154

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 6MM STP RT
OSTEOMED LLC
213-0153
In Commercial Distribution

  • 00842528125656 ()
213-0153

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 6MM STP LF
OSTEOMED LLC
213-0152
In Commercial Distribution

  • 00842528125649 ()
213-0152

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6MM PRE-BENT 13 HOLE PLT 4MM STP RT
OSTEOMED LLC
213-0151
In Commercial Distribution

  • 00842528125632 ()
213-0151

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