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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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CERTEX 4.0 X 24mm THREADED X 16mm SMOOTH X 40mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-1556
Not in Commercial Distribution

  • M697X06715561 ()

  • Length: 24 Millimeter
  • Length: 16 Millimeter
  • Outer Diameter: 4 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 4.0 X 24mm THREADED X 10mm SMOOTH X 34mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-1554
Not in Commercial Distribution

  • M697X06715541 ()

  • Length: 24 Millimeter
  • Outer Diameter: 4 Millimeter
  • Length: 10 Millimeter


  • Spinal bone screw, non-bioabsorbable
15.5F x 24cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip)
ANGIODYNAMICS, INC.
10302803
In Commercial Distribution

  • H787103028031 ()
  • H787103028030 ()
  • H787103028035 ()
  • 15051684011839 ()

  • Length: 24 Centimeter
  • Needle Gauge: 18 Gauge
  • 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
DuraFlow 2 - 15.5F x 24cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip)
ANGIODYNAMICS, INC.
10301201
In Commercial Distribution

  • H787103012015 ()
  • H787103012010 ()
  • H787103012011 ()
  • 15051684014731 ()

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


  • Double-lumen haemodialysis catheter, implantable
15.5F x 24cm Dura-Flow with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 19cm from Tip)
ANGIODYNAMICS, INC.
10301101
Not in Commercial Distribution

  • H787103011015 ()
  • H787103011010 ()

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


  • Double-lumen haemodialysis catheter, implantable
14.5F x 24cm Chronic Hemodialysis Pre-Curve Catheter Set (with Cuff 19cm from Tip)
ANGIODYNAMICS, INC.
10303507
In Commercial Distribution

  • H787103035075 ()
  • H787103035070 ()
  • 15051684014311 ()

  • Catheter Gauge: 14.5 French
  • Length: 24 Centimeter
  • Needle Gauge: 18 Gauge


  • Double-lumen haemodialysis catheter, implantable
14.5F x 24cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip)
ANGIODYNAMICS, INC.
10303501
In Commercial Distribution

  • H787103035015 ()
  • H787103035010 ()
  • 15051684014250 ()

  • Catheter Gauge: 14.5 French
  • Length: 24 Centimeter
  • Needle Gauge: 18 Gauge


  • Double-lumen haemodialysis catheter, implantable
15.5Fx24cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter VascPak Kit
NAVILYST MEDICAL, INC.
03-818
In Commercial Distribution

  • H965103038181 ()
  • H965103038180 ()
  • 15051684025683 ()

  • Length: 24 Centimeter
  • Outer Diameter: 5.2 Millimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable
15.5Fx24cm BioFlo DuraMax with ENDEXO Technology Chronic Hemodialysis Catheter Kit
NAVILYST MEDICAL, INC.
02-903
In Commercial Distribution

  • H965103029031 ()
  • H965103029030 ()
  • 15051684025775 ()

  • Outer Diameter: 5.2 Millimeter
  • Length: 24 Centimeter
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable
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