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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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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
Straight Plate - Low-Profile - 2 hole - 11 mm (3), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3590
In Commercial Distribution

  • M3848135901 ()
  • M3848135900 ()
81-3590

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Flexible Burr Hole Cover - Ø1.9 mm - 18 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3588[US]
In Commercial Distribution

  • M384813588US1 ()
  • M384813588US0 ()
81-3588[US]

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Flexible Burr Hole Cover - Ø1.9 mm - 18 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3588
In Commercial Distribution

  • M3848135881 ()
  • M3848135880 ()
81-3588

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Boxcar Plate - Ø1.9 mm - 4 hole - 11 x 11 mm (1), Self-Drilling Screw - 4 mm (4) [5 PK]
Bioplate, Inc.
81-3587
In Commercial Distribution

  • M3848135871 ()
  • M3848135870 ()
81-3587

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
X Plate - Ø1.9 mm - 6 hole - 18 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3586[US]
In Commercial Distribution

  • M384813586US1 ()
  • M384813586US0 ()
81-3586[US]

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
X Plate - Ø1.9 mm - 6 hole - 18 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3586
In Commercial Distribution

  • M3848135861 ()
  • M3848135860 ()
81-3586

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
Compression Plate - Ø1.9 mm - 2 hole - 15 mm (3), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3582
In Commercial Distribution

  • M3848135821 ()
  • M3848135820 ()
81-3582

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