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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® - M3848134880

Triangle Plate - Ø1.5 mm - 3 hole - 16 mm
Bioplate, Inc.
81-3488
In Commercial Distribution

  • M3848134880 ()

  • Length: 16 Millimeter
81-3488

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

Bioplate® - M3848134050

Locking Clutch Driver Handle Only
Bioplate, Inc.
81-3405
In Commercial Distribution

  • M3848134050 ()

  • Length: 3.93 Inch
81-3405

  • Surgical screwdriver, reusable

Bioplate® - M384813379US0

BioMesh® Gap Plate - 43 x 109 mm
Bioplate, Inc.
81-3379[US]
In Commercial Distribution

  • M384813379US0 ()

  • Length: 109 Millimeter
81-3379[US]

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

Bioplate® - M384813379CP0

BioMesh® Gap Plate - 43 x 109 mm
Bioplate, Inc.
81-3379-CP
In Commercial Distribution

  • M384813379CP0 ()

  • Length: 109 Millimeter
81-3379-CP

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

Bioplate® - M3848133790

BioMesh® Gap Plate - 43 x 109 mm
Bioplate, Inc.
81-3379
In Commercial Distribution

  • M3848133790 ()

  • Length: 109 Millimeter
81-3379

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

Bioplate® - M3848133730

Compression X Plate - Ø1.9 mm - 6 hole - 18 mm
Bioplate, Inc.
81-3373
In Commercial Distribution

  • M3848133730 ()

  • Length: 18 Millimeter
81-3373

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

Bioplate® - M3848133720

Compression Burr Hole Cover - Ø1.9 mm - 6 hole - 18 mm
Bioplate, Inc.
81-3372
In Commercial Distribution

  • M3848133720 ()

  • Length: 18 Millimeter
81-3372

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

Bioplate® - M3848133700

Compression Burr Hole Cover - Ø1.5 mm - 6 hole - 18 mm
Bioplate, Inc.
81-3370
In Commercial Distribution

  • M3848133700 ()

  • Length: 18 Millimeter
81-3370

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

Bioplate® - M3848133640

Xpress® Compact Kit
Bioplate, Inc.
81-3364
In Commercial Distribution

  • M3848133640 ()
81-3364

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable

Bioplate® - M3848133610

Xpress ® Screwdriver blade - 1.5mm diam.
Bioplate, Inc.
81-3361
In Commercial Distribution

  • M3848133610 ()

  • Length: 2.96 Inch
81-3361

  • Surgical screwdriver, reusable
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