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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T Plate - Low-Profile - 5 hole - 15 mm (1), Self-Drilling Screw - 4 mm (5) [5 PK]
Bioplate, Inc.
81-5887
In Commercial Distribution

  • M3848158871 ()
  • M3848158870 ()
81-5887

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Boxcar Plate - Low-Profile - 4 hole - 10 mm (1), Self-Drilling Screw - 4 mm (4) [5 PK]
Bioplate, Inc.
81-5886
In Commercial Distribution

  • M3848158861 ()
  • M3848158860 ()
81-5886

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
X Plate - Low-Profile - 6 hole - 17 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-5885
In Commercial Distribution

  • M3848158851 ()
  • M3848158850 ()
81-5885

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Straight Plate - Ø1.9 mm - 2 hole - 15 mm (1), Self-Drilling Screw - 4 mm (2) [5 PK]
Bioplate, Inc.
81-5715
In Commercial Distribution

  • M3848159151 ()
  • M3848157150 ()
81-5715

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Straight Plate - Ø1.5 mm - 2 hole - 14 mm (1), Self-Drilling Screw - 4 mm (2) [5 PK]
Bioplate, Inc.
81-5712
In Commercial Distribution

  • M3848159121 ()
  • M3848157120 ()
81-5712

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Burr Hole Cover - Low-Profile - 12 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3593
In Commercial Distribution

  • M3848135931 ()
  • M3848135930 ()
81-3593

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Burr Hole Cover - Low-Profile - 18 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3592[US]
In Commercial Distribution

  • M384813592US1 ()
  • M384813592US0 ()
81-3592[US]

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Burr Hole Cover - Low-Profile - 18 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3592
In Commercial Distribution

  • M3848135921 ()
  • M3848135920 ()
81-3592

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Straight Plate - Low-Profile - 2 hole - 14 mm (3), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3591[US]
In Commercial Distribution

  • M384813591US1 ()
  • M384813591US0 ()
81-3591[US]

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Straight Plate - Low-Profile - 2 hole - 14 mm (3), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3591
In Commercial Distribution

  • M3848135911 ()
  • M3848135910 ()
81-3591

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