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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
Hex Nut Screw Driver
BAUI BIOTECH CO. LTD.
409-0829F
In Commercial Distribution

  • 04710577043473 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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
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