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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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BioFlo PICC with Endexo and PASV Valve Technology - 5F x 55cm Catheter MST-70 Kit with Nitinol Wire
NAVILYST MEDICAL, INC.
45892
In Commercial Distribution

  • H965458920 ()
  • 15051684025102 ()

  • Needle Gauge: 21 Gauge
  • Length: 55 Centimeter
  • Catheter Gauge: 5 French
  • Outer Diameter: 1.7 Millimeter


  • Peripherally-inserted central venous catheter
BioFlo PICC with Endexo and PASV Valve Technology - 4F x 55cm Catheter Intermediate MST-45 Kit with Lidocaine
NAVILYST MEDICAL, INC.
45815
In Commercial Distribution

  • H965458150 ()
  • 15051684026154 ()

  • Needle Gauge: 21 Gauge
  • Length: 55 Centimeter
  • Outer Diameter: 1.4 Millimeter
  • Pressure: 325 Pound per Square Inch
  • Catheter Gauge: 4 French


  • Peripherally-inserted central venous catheter
BioFlo PICC with Endexo and PASV Valve Technology - 3F x 55cm Catheter Intermediate MST-45 Kit with Lidocaine
NAVILYST MEDICAL, INC.
45805
In Commercial Distribution

  • H965458050 ()
  • 15051684026130 ()

  • Needle Gauge: 21 Gauge
  • Pressure: 325 Pound per Square Inch
  • Outer Diameter: 1.05 Millimeter
  • Length: 55 Centimeter
  • Catheter Gauge: 3 French


  • Peripherally-inserted central venous catheter
BioFlo Titanium Port with Non Filled Suture Holes and 8F x 63cm Polyurethane Catheter with ENDEXO Technology
NAVILYST MEDICAL, INC.
44017
Not in Commercial Distribution

  • H965440170 ()

  • Length: 63 Centimeter
  • Pressure: 300 Pound per Square Inch
  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 8 French
  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 2.6 Millimeter


  • Vascular port/catheter
BioFlo Titanium Port with Non Filled Suture Holes and 6F x 63cm Polyurethane Catheter with ENDEXO Technology
NAVILYST MEDICAL, INC.
44015
Not in Commercial Distribution

  • H965440150 ()

  • Pressure: 300 Pound per Square Inch
  • Catheter Gauge: 6 French
  • Outer Diameter: 2.1 Millimeter
  • Length: 63 Centimeter
  • Needle Gauge: 18 Gauge
  • Lumen/Inner Diameter: 1.3 Millimeter


  • Vascular port/catheter
BioFlo Plastic Port with Non Filled Suture Holes and 8F x 63cm Polyurethane Catheter with ENDEXO Technology
NAVILYST MEDICAL, INC.
44013
Not in Commercial Distribution

  • H965440130 ()

  • Pressure: 300 Pound per Square Inch
  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 8 French
  • Lumen/Inner Diameter: 1.6 Millimeter
  • Length: 63 Centimeter
  • Outer Diameter: 2.6 Millimeter


  • Vascular port/catheter
BioFlo Plastic Port with Non Filled Suture Holes and 6F x 63cm Polyurethane Catheter with ENDEXO Technology
NAVILYST MEDICAL, INC.
44011
Not in Commercial Distribution

  • H965440110 ()

  • Length: 63 Centimeter
  • Catheter Gauge: 6 French
  • Lumen/Inner Diameter: 1.3 Millimeter
  • Needle Gauge: 18 Gauge
  • Pressure: 300 Pound per Square Inch
  • Outer Diameter: 2.1 Millimeter


  • Vascular port/catheter
Phasor Drill 6.35-mm diameter, ~70-mm usable length with drill stop extension (tapered) + Kit (version A1) with Stapler
PHASOR HEALTH LLC
PH-635-70-DT + PH-K-A1S
In Commercial Distribution

  • B775PH63570DTPHKA1S0 ()
PH-635-70-DT + PH-K-A1S

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
Phasor Drill 6.35-mm diameter, ~70-mm usable length with drill stop extension (tapered) + Kit (version A1) with Stapler
PHASOR HEALTH LLC
6.35K
In Commercial Distribution

  • B775635K0 ()
6.35K

  • Neurosurgical procedure kit, medicated
  • Automatic cranial perforator, single-use
  • Skin stapler/staple, non-bioabsorbable
Phasor Drill 5.80-mm diameter, ~70-mm usable length with drill stop extension (tapered) + Kit (version A1) with Stapler
PHASOR HEALTH LLC
5.80K
In Commercial Distribution

  • B775580K0 ()
5.80K

  • Neurosurgical procedure kit, medicated
  • Automatic cranial perforator, single-use
  • Skin stapler/staple, non-bioabsorbable
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