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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® - M384813588US0

Flexible Burr Hole Cover - Ø1.9 mm - 18 mm (1), Self-Drilling Screw - 4 mm (6) [5 PK]
Bioplate, Inc.
81-3588[US]
In Commercial Distribution

  • M384813588US1 ()
  • M384813588US0 ()
81-3588[US]

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

Bioplate® - M384813528US1

Straight Plate - Low-Profile - 2 hole - 14 mm [50 PK]
Bioplate, Inc.
81-3528[US]
In Commercial Distribution

  • M384813528US1 ()
  • M384813528US0 ()

  • Length: 14 Millimeter
81-3528[US]

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

Bioplate® - M3848135191

Straight Plate - Low-Profile - 2 hole - 11 mm [50 PK]
Bioplate, Inc.
81-3519
In Commercial Distribution

  • M3848135191 ()
  • M3848135190 ()

  • Length: 11 Millimeter
81-3519

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

Bioplate® - M3848134370

BioMesh® 3MC - 10 x 20 cm
Bioplate, Inc.
81-3437
In Commercial Distribution

  • M3848134370 ()

  • Length: 20 Centimeter
81-3437

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

Bioplate® - M3848133710

Compression X Plate - Ø1.5 mm - 6 hole - 17 mm
Bioplate, Inc.
81-3371
In Commercial Distribution

  • M3848133710 ()

  • Length: 17 Millimeter
81-3371

  • 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® - M384813184CP0

Biomesh® Gap Plate - 29 x 88 mm
Bioplate, Inc.
81-3184-CP
In Commercial Distribution

  • M384813184CP0 ()

  • Length: 88 Millimeter
81-3184-CP

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

Bioplate® - M384813181US0

Access Burr Hole Cover - Ø1.9 mm - 5 hole - 18 mm
Bioplate, Inc.
81-3181[US]
In Commercial Distribution

  • M384813181US0 ()

  • Length: 18 Millimeter
81-3181[US]

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

Bioplate® - M3848131810

Access Burr Hole Cover - Ø1.9 mm - 5 hole - 18 mm
Bioplate, Inc.
81-3181
In Commercial Distribution

  • M3848131810 ()

  • Length: 18 Millimeter
81-3181

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

Bioplate® - M3848131800

Access Burr Hole Cover - Ø1.5 mm - 5 hole - 18 mm
Bioplate, Inc.
81-3180
In Commercial Distribution

  • M3848131800 ()

  • Length: 18 Millimeter
81-3180

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