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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® - 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® - M3848133670

Compact Plus Kit Low Profile System
Bioplate, Inc.
81-3367
In Commercial Distribution

  • M3848133670 ()
81-3367

  • 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® - 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

Bioplate® - M3848133600

Xpress® Screwdriver Handle Only
Bioplate, Inc.
81-3360
In Commercial Distribution

  • M3848133600 ()

  • Length: 3.61 Inch
81-3360

  • Surgical screwdriver, reusable

Bioplate® - M3848133560

Xpress® Burr Hole Cover - Ø1.5 mm - 6 hole - 19 mm
Bioplate, Inc.
81-3356
In Commercial Distribution

  • M3848133560 ()

  • Length: 19 Millimeter
81-3356

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

Bioplate® - M3848133550

Xpress® Boxcar Plate - Ø1.5 mm - 4 hole - 13 mm
Bioplate, Inc.
81-3355
In Commercial Distribution

  • M3848133550 ()

  • Length: 13 Millimeter
81-3355

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

Bioplate® - M3848133540

Xpress ® X Plate - Ø1.5 mm - 6 hole - 18 mm
Bioplate, Inc.
81-3354
In Commercial Distribution

  • M3848133540 ()

  • Length: 18 Millimeter
81-3354

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

Bioplate® - M3848133520

Xpress® Straight Plate - Ø1.5 mm - 4 hole - 21 mm
Bioplate, Inc.
81-3352
In Commercial Distribution

  • M3848133520 ()

  • Length: 21 Millimeter
81-3352

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

Bioplate® - M3848133511

Xpress® Straight Plate - Ø1.5 mm - 2 hole - 14 mm [50 PK]
Bioplate, Inc.
81-3351
In Commercial Distribution

  • M3848133511 ()
  • M3848133510 ()

  • Length: 14 Millimeter
81-3351

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