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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® - M3848173630

Straight Plate - Ø1.9 mm - 2 hole - 15 mm (1), Self-Drilling Screw - 5 mm (2) [5 PK]
Bioplate, Inc.
81-7363
In Commercial Distribution

  • M3848173631 ()
  • M3848173630 ()
81-7363

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

Bioplate® - M3848173330

Flexible Burr Hole Cover - Ø1.5 mm - 18 mm (1), Self-Drilling Screw - 4 mm (4) [5 PK]
Bioplate, Inc.
81-7333
In Commercial Distribution

  • M3848173331 ()
  • M3848173330 ()
81-7333

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

Bioplate® - M3848173230

Self-Drilling Screw - Low-Profile - 4 mm (6) [5 PK]
Bioplate, Inc.
81-7323
In Commercial Distribution

  • M3848173231 ()
  • M3848173230 ()
81-7323

  • Neurosurgical procedure kit, non-medicated, single-use

Bioplate® - M3848173220

Self-Drilling Screw - Low-Profile - 4 mm (4) [5 PK]
Bioplate, Inc.
81-7322
In Commercial Distribution

  • M3848173221 ()
  • M3848173220 ()
81-7322

  • Neurosurgical procedure kit, non-medicated, single-use

Bioplate® - M3848173200

Flexible Burr Hole Cover - Ø1.9 mm - 18 mm (1) [5 PK]
Bioplate, Inc.
81-7320
In Commercial Distribution

  • M3848173201 ()
  • M3848173200 ()
81-7320

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

Bioplate® - M3848173140

Straight Plate - Ø1.9 mm - 2 hole - 15 mm (1) [5 PK]
Bioplate, Inc.
81-7314
In Commercial Distribution

  • M3848173141 ()
  • M3848173140 ()
81-7314

  • Neurosurgical procedure kit, non-medicated, single-use

Bioplate® - M3848173110

Self-Drilling Screw - Ø1.9 mm x 4 mm (2) [5 PK]
Bioplate, Inc.
81-7311
In Commercial Distribution

  • M3848173111 ()
  • M3848173110 ()
81-7311

  • Neurosurgical procedure kit, non-medicated, single-use

Wavicide-01 - M445011232OZ0

Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes.
MEDICAL CHEMICAL CORPORATION
0112-32oz
In Commercial Distribution

  • M445011232OZ1 ()
  • M445011232OZ0 ()
0112-32oz

  • Glutaraldehyde device sterilant

Wavicide-01 - M44501041GL0

Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes.
MEDICAL CHEMICAL CORPORATION
0104-1gl
In Commercial Distribution

  • M44501041GL1 ()
  • M44501041GL0 ()
0104-1gl

  • Glutaraldehyde device sterilant

Cardiva Catalyst III VCS - M729600580CP0

The Cardiva Catalyst III consists of a sterile disposable Catalyst III Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III is specifically designed for use with heparinized patients. The Cardiva Catalyst III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst III is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.
CARDIVA MEDICAL, INC.
600-580CP
In Commercial Distribution

  • M729600580CP2 ()
  • M729600580CP0 ()

  • Catheter Gauge: 6 French
  • Catheter Gauge: 7 French
  • Catheter Gauge: 5 French


  • Femoral artery compression system, single-use
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