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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® - M3848133490

Xpress® Straight Plate - Ø1.5 mm - 2 hole - 14 mm
Bioplate, Inc.
81-3349
In Commercial Distribution

  • M3848133490 ()

  • Length: 14 Millimeter
81-3349

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

Bioplate® - M3848133400

Compact Plus Kit ø1.5mm System
Bioplate, Inc.
81-3340
In Commercial Distribution

  • M3848133400 ()
81-3340

  • 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® - M384813060US0

Straight Plate - Ø1.5 mm - 16 hole - 63 mm
Bioplate, Inc.
81-3060[US]
In Commercial Distribution

  • M384813060US0 ()

  • Length: 63 Millimeter
81-3060[US]

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

Bioplate® - M3848130590

Curved Plate - Ø1.5 mm - 8 hole - 30 mm
Bioplate, Inc.
81-3059
In Commercial Distribution

  • M3848130590 ()

  • Length: 30 Millimeter
81-3059

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

Bioplate® - M384813048CP1

Straight Plate - Ø1.9 mm - 2 hole - 12 mm
Bioplate, Inc.
81-3048-CP
In Commercial Distribution

  • M384813048CP1 ()
  • M384813048CP0 ()

  • Length: 12 Millimeter
81-3048-CP

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

Bioplate® - M3848130460

Screwdriver - 1.9mm diam.
Bioplate, Inc.
81-3046
In Commercial Distribution

  • M3848130460 ()

  • Length: 6.4 Inch
81-3046

  • Surgical screwdriver, reusable

Bioplate® - M3848130250

BioMesh® 3MC - 65 x 65 mm
Bioplate, Inc.
81-3025
In Commercial Distribution

  • M3848130250 ()

  • Length: 65 Millimeter
81-3025

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

Bioplate® - M384813024US0

BioMesh® 3MC - 36 x 52 mm
Bioplate, Inc.
81-3024[US]
In Commercial Distribution

  • M384813024US0 ()

  • Length: 52 Millimeter
81-3024[US]

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

Bioplate® - M384813023US0

BioMesh® 2MC - 85 x 90 mm
Bioplate, Inc.
81-3023[US]
In Commercial Distribution

  • M384813023US0 ()

  • Length: 90 Millimeter
81-3023[US]

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

Bioplate® - M3848130230

BioMesh® 2MC - 85 x 90 mm
Bioplate, Inc.
81-3023
In Commercial Distribution

  • M3848130230 ()

  • Length: 90 Millimeter
81-3023

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