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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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Poly Axial Screw Adjustable Driver
BAUI BIOTECH CO. LTD.
409-0813B
In Commercial Distribution

  • 04710577040939 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
U2 Total Knee System
UNITED ORTHOPEDIC CORP.
9104-1107
In Commercial Distribution

  • 04711605582490 ()
9104-1107

  • Orthopaedic inorganic implant inserter/extractor, reusable
Implant Adaptor
COHO BIOMEDICAL TECHNOLOGY CO., LTD.
Me-A4815
In Commercial Distribution

  • 04710986432646 ()


  • Surgical torque wrench adaptor
1.6 System Right Pterional Mesh Sterile Qty 2
OSTEOMED LLC
218-2016-SP-02
In Commercial Distribution

  • 00845694066082 ()

  • Length: 92 Millimeter
218-2016-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
1.6 System Left Pterional Mesh Sterile Qty 2
OSTEOMED LLC
218-2015-SP-02
In Commercial Distribution

  • 00845694066068 ()

  • Length: 92 Millimeter
218-2015-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 65 x 90mm Mesh Sterile Qty 1
OSTEOMED LLC
218-0290-SP-01
In Commercial Distribution

  • 00845694065986 ()

  • Length: 90 Millimeter
218-0290-SP-01

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 80 x 50mm Mesh Sterile Qty 1
OSTEOMED LLC
218-0285-SP-01
In Commercial Distribution

  • 00845694065962 ()

  • Length: 79 Millimeter
218-0285-SP-01

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 2 Long Straight Plate Sterile Qty 5
OSTEOMED LLC
218-0217-SP-05
In Commercial Distribution

  • 00845694065948 ()

  • Length: 19 Millimeter
218-0217-SP-05

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 45 Gap Plate Sterile Qty 2
OSTEOMED LLC
218-0216-SP-02
In Commercial Distribution

  • 00845694065924 ()

  • Length: 50 Millimeter
218-0216-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 35 Gap Plate Sterile Qty 2
OSTEOMED LLC
218-0215-SP-02
In Commercial Distribution

  • 00845694065900 ()

  • Length: 39 Millimeter
218-0215-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 25 Gap Plate Sterile Qty 2
OSTEOMED LLC
218-0214-SP-02
In Commercial Distribution

  • 00845694065887 ()

  • Length: 29 Millimeter
218-0214-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 Bur Hole Groove Shunt Plate Sterile Qty 5
OSTEOMED LLC
218-0213-SP-05
In Commercial Distribution

  • 00845694065863 ()

  • Outer Diameter: 27 Millimeter
218-0213-SP-05

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 X- Large Bur Hole Plate Sterile Qty 2
OSTEOMED LLC
218-0212-SP-02
In Commercial Distribution

  • 00845694065849 ()

  • Outer Diameter: 31 Millimeter
218-0212-SP-02

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 Large Bur Hole Plate Sterile Qty 5
OSTEOMED LLC
218-0211-SP-05
In Commercial Distribution

  • 00845694065825 ()

  • Outer Diameter: 27 Millimeter
218-0211-SP-05

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 Small Bur Hole Plate Sterile Qty 5
OSTEOMED LLC
218-0210-SP-05
In Commercial Distribution

  • 00845694065801 ()

  • Outer Diameter: 20 Millimeter
218-0210-SP-05

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 2 x 4 Hole Quad Plate Sterile Qty 5
OSTEOMED LLC
218-0209-SP-05
In Commercial Distribution

  • 00845694065788 ()

  • Length: 26 Millimeter
218-0209-SP-05

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 2 x 3 Hole Quad Plate Sterile Qty 5
OSTEOMED LLC
218-0208-SP-05
In Commercial Distribution

  • 00845694065764 ()

  • Length: 19 Millimeter
218-0208-SP-05

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 9mm Square Plate Sterile Qty 5
OSTEOMED LLC
218-0207-SP-05
In Commercial Distribution

  • 00845694065740 ()

  • Length: 14 Millimeter
218-0207-SP-05

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 Doube Y Plate Sterile Qty 5
OSTEOMED LLC
218-0206-SP-05
In Commercial Distribution

  • 00845694065726 ()

  • Length: 20 Millimeter
218-0206-SP-05

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Profile 0 Y Plate Sterile Qty 5
OSTEOMED LLC
218-0205-SP-05
In Commercial Distribution

  • 00845694065702 ()

  • Length: 19 Millimeter
218-0205-SP-05

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