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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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Bioplate® - M3848157150

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

Bioplate® - M3848157120

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

Bioplate® - M3848135930

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

Bioplate® - M384813592US0

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

Bioplate® - M3848135920

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

Bioplate® - M384813591US0

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

Bioplate® - M3848135910

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

Bioplate® - M3848135900

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

Bioplate® - M384813588US0

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

Bioplate® - M3848135880

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
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