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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® - 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® - M3848135750

Straight Plate - Ø1.5 mm - 2 hole - 11 mm (3), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3575
In Commercial Distribution

  • M3848135751 ()
  • M3848135750 ()
81-3575

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

Bioplate® - M3848135740

Compression Plate - Ø1.5 mm - 2 hole - 14 mm (3), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3574
In Commercial Distribution

  • M3848135741 ()
  • M3848135740 ()
81-3574

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

Bioplate® - M384813573US0

Straight Plate - Ø1.5 mm - 2 hole - 14 mm (3), Self-Drilling Screw - 4 mm (6) [10 PK]
Bioplate, Inc.
81-3573[US]
In Commercial Distribution

  • M384813573US1 ()
  • M384813573US0 ()
81-3573[US]

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

Bioplate® - M3848135730

Straight Plate - Ø1.5 mm - 2 hole - 14 mm (3), Self-Drilling Screw - 4 mm (6) [10 PK]
Bioplate, Inc.
81-3573
In Commercial Distribution

  • M3848135731 ()
  • M3848135730 ()
81-3573

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

Valkyrie Rib Thoracic Fixation System - 00810071390876

Rib Screw Driver Bit
J.M. Longyear Manufacturing, LLC
05-01-2528
In Commercial Distribution

  • 00810071390876 ()
05-01-2528

  • Surgical screwdriver, single-use

Valkyrie Thoracic Fixation System - 00810071390647

Driver Bit
J.M. Longyear Manufacturing, LLC
01-01-3035
In Commercial Distribution

  • 00810071390647 ()
01-01-3035

  • Surgical screwdriver, single-use
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