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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 Technology - 5F x 55cm Dual Lumen Catheter Intermediate MST-45 Kit with Lidocaine
NAVILYST MEDICAL, INC.
45874
In Commercial Distribution

  • H965458740 ()
  • 15051684026055 ()

  • Pressure: 325 Pound per Square Inch
  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.75 Millimeter
  • Catheter Gauge: 5 French
  • Length: 55 Centimeter


  • Peripherally-inserted central venous catheter
BioFlo Dual Port with Endexo Technology - Plastic Port with Filled Suture Holes and 8F Polyurethane Catheter
NAVILYST MEDICAL, INC.
44028
Not in Commercial Distribution

  • H965440280 ()

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


  • Vascular port/catheter
BioFlo Dual Port with Endexo Technology - Plastic Port with Non-Filled Suture Holes and 8F Polyurethane Catheter
NAVILYST MEDICAL, INC.
44027
Not in Commercial Distribution

  • H965440270 ()

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


  • Vascular port/catheter
BioFlo Plastic Port with Filled Suture Holes and 8F x 63cm Polyurethane Catheter with ENDEXO Technology
NAVILYST MEDICAL, INC.
44014
Not in Commercial Distribution

  • H965440140 ()

  • 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
  • Length: 63 Centimeter


  • Vascular port/catheter
BioFlo Plastic Port with Filled Suture Holes and 6F x 63cm Polyurethane Catheter with ENDEXO Technology
NAVILYST MEDICAL, INC.
44012
Not in Commercial Distribution

  • H965440120 ()

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


  • Vascular port/catheter
MICTEC HF FLAT ELECTRODE WITH LATERAL SLOTS AND CENTRAL HOLE CURVED WITH CONNECTION TO SUCTION-IRRIGATION VALVES
SONTEC INSTRUMENTS, INC.
20947-11-002
In Commercial Distribution


  • 7mm 30° Tip
  • Length: 300 Millimeter
  • 10mm Valve Connection


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
80 in. (200 cm) Spike with Drip Chamber For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-160CYRV
Not in Commercial Distribution

  • B101A120160CYRV1 ()
  • B101A120160CYRV0 ()


  • Electric infusion pump administration set, single-use
80 in. (200 cm) Spike with Drip Chamber For Use with the CMExpress® Infusion Pump
CME AMERICA LLC
A120-160CYFRV
Not in Commercial Distribution

  • B101A120160CYFRV1 ()
  • B101A120160CYFRV0 ()


  • Electric infusion pump administration set, single-use
MICTEC HF FLAT ELECTRODE WITH LATERAL SLOTS AND CENTRAL HOLE CURVED WITH CONNECTION TO SUCTION-IRRIGATION VALVES
SONTEC INSTRUMENTS, INC.
20947-11-002
Not in Commercial Distribution

  • B09920947110020 ()

  • 10mm Valve Connection
  • Length: 300 Millimeter
  • 7mm 30° Tip


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
9 inch Jacobson Heavy Needle Holder, Straight TC With Lock, Use With 1-0,2-0, And 3-0 Surture
Surgical Direct, Inc.
SD905679108
In Commercial Distribution

  • B382SD9056791080 ()
SD905679108

  • Suturing needle holder, reusable
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