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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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Phasor Drill, 5.30-mm diameter, with Drill stop extension, Tapered, plus Kit (version A1) with stapler
PHASOR HEALTH LLC
PH-530-70-DT + PH-K-A1S
In Commercial Distribution

  • B775PH53070DTPHKA1S0 ()
PH-530-70-DT + PH-K-A1S

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
  • Skin stapler/staple, non-bioabsorbable
Phasor Drill, 5.30-mm diameter, with Drill stop extension, Tapered, plus Kit (version A1) with stapler
PHASOR HEALTH LLC
5.30K
In Commercial Distribution

  • B775530K0 ()
5.30K

  • Neurosurgical procedure kit, medicated
  • Skin stapler/staple, non-bioabsorbable
  • Automatic cranial perforator, single-use
Xcela PICC with PASV Valve Technology - 6Fx55cm Triple Lumen Catheter Intermediate MST-45 Kit with Lidocaine
NAVILYST MEDICAL, INC.
45745
In Commercial Distribution

  • H965457450 ()

  • Needle Gauge: 21 Gauge
  • Length: 55 Centimeter
  • Catheter Gauge: 6 French
  • Outer Diameter: 2.2 Millimeter
  • Pressure: 325 Pound per Square Inch


  • Peripherally-inserted central venous catheter
Xcela PICC with PASV Valve Technology - 5Fx55cm Dual Lumen Catheter Intermediate MST-45 Kit with Lidocaine
NAVILYST MEDICAL, INC.
45735
In Commercial Distribution

  • H965457350 ()

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


  • Peripherally-inserted central venous catheter
15.5F x 20cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 15cm from Tip)
ANGIODYNAMICS, INC.
10301213
Not in Commercial Distribution

  • H787103012135 ()
  • H787103012130 ()

  • Length: 20 Centimeter
  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable
15.5F x 36cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 31cm from Tip)
ANGIODYNAMICS, INC.
10301209
In Commercial Distribution

  • H787103012095 ()
  • H787103012090 ()

  • Catheter Gauge: 15.5 French
  • Needle Gauge: 18 Gauge
  • Length: 36 Centimeter


  • Double-lumen haemodialysis catheter, implantable
15.5F x 32cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 27cm from Tip)
ANGIODYNAMICS, INC.
10301208
In Commercial Distribution

  • H787103012085 ()
  • H787103012080 ()

  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 15.5 French
  • Length: 32 Centimeter


  • Double-lumen haemodialysis catheter, implantable
15.5F x 28cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 23cm from Tip)
ANGIODYNAMICS, INC.
10301207
In Commercial Distribution

  • H787103012075 ()
  • H787103012070 ()

  • Needle Gauge: 18 Gauge
  • Length: 28 Centimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable
15.5F x 24cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 19cm from Tip)
ANGIODYNAMICS, INC.
10301206
In Commercial Distribution

  • H787103012065 ()
  • H787103012060 ()

  • Catheter Gauge: 15.5 French
  • Length: 24 Centimeter
  • Needle Gauge: 18 Gauge


  • Double-lumen haemodialysis catheter, implantable
15.5F x 32cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 27cm from Tip)
ANGIODYNAMICS, INC.
10301108
Not in Commercial Distribution

  • H787103011085 ()
  • H787103011080 ()

  • Catheter Gauge: 15.5 French
  • Needle Gauge: 18 Gauge
  • Length: 32 Centimeter


  • Double-lumen haemodialysis catheter, implantable
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