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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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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
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 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 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
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
The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst II 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.
500-580C
In Commercial Distribution

  • M729500580C2 ()
  • M729500580C0 ()

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


  • Femoral artery compression system, single-use
No Description
OPHTHALMED LLC
B62B513
Not in Commercial Distribution

  • M735B62B5135 ()
  • M735B62B5131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
B62B413
Not in Commercial Distribution

  • M735B62B4135 ()
  • M735B62B4131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
B62B313
Not in Commercial Distribution

  • M735B62B3135 ()
  • M735B62B3131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
B62B213
Not in Commercial Distribution

  • M735B62B2135 ()
  • M735B62B2131 ()

  • Needle Gauge: 23 Gauge


  • Ophthalmic laser system beam guide
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