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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® - 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

Bioplate® - M3848135870

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

Bioplate® - M384813586US0

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

Bioplate® - M3848135860

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

Bioplate® - M3848135820

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

Bioplate® - M384813581US0

Straight Plate - Ø1.9 mm - 2 hole - 15 mm (3), Self-Drilling Screw - 4 mm (6) [10 PK]
Bioplate, Inc.
81-3581[US]
In Commercial Distribution

  • M384813581US1 ()
  • M384813581US0 ()
81-3581[US]

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

Bioplate® - M3848135810

Straight Plate - Ø1.9 mm - 2 hole - 15 mm (3), Self-Drilling Screw - 4 mm (6) [10 PK]
Bioplate, Inc.
81-3581
In Commercial Distribution

  • M3848135811 ()
  • M3848135810 ()
81-3581

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