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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® - 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

Bioplate® - M384813580US0

Flexible Burr Hole Cover - Ø1.5 mm - 18 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3580[US]
In Commercial Distribution

  • M384813580US1 ()
  • M384813580US0 ()
81-3580[US]

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

Bioplate® - M3848135800

Flexible Burr Hole Cover - Ø1.5 mm - 18 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3580
In Commercial Distribution

  • M3848135801 ()
  • M3848135800 ()
81-3580

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

Bioplate® - M3848135790

Boxcar Plate - Ø1.5 mm - 4 hole - 10 x 10 mm (1), Self-Drilling Screw - 4 mm (4) [5 PK]
Bioplate, Inc.
81-3579
In Commercial Distribution

  • M3848135791 ()
  • M3848135790 ()
81-3579

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

Bioplate® - M3848135780

X Plate - Ø1.5 mm - 6 hole - 17 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3578
In Commercial Distribution

  • M3848135781 ()
  • M3848135780 ()
81-3578

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

Bioplate® - M3848158930

Straight Plate - Low-Profile - 2 hole - 14 mm (1), Self-Drilling Screw - 4 mm (2) [5 PK]
Bioplate, Inc.
81-5893
In Commercial Distribution

  • M3848158931 ()
  • M3848158930 ()
81-5893

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

Bioplate® - M3848158920

Straight Plate - Low-Profile - 2 hole - 14 mm (2), Self-Drilling Screw - 4 mm (4) [5 PK]
Bioplate, Inc.
81-5892
In Commercial Distribution

  • M3848158921 ()
  • M3848158920 ()
81-5892

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

Bioplate® - M3848158880

Straight Plate - Low-Profile - 4 hole - 19 mm (1), Self-Drilling Screw - 4 mm (4) [5 PK
Bioplate, Inc.
81-5888
In Commercial Distribution

  • M3848158881 ()
  • M3848158880 ()
81-5888

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

Bioplate® - M3848158870

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
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