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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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DuraFlow 2 - 15.5F x 28cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip)
ANGIODYNAMICS, INC.
10301202
In Commercial Distribution

  • H787103012025 ()
  • H787103012020 ()
  • H787103012021 ()
  • 15051684014748 ()

  • Length: 28 Centimeter
  • Catheter Gauge: 15.5 French
  • 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
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution

  • M729700580I1 ()
  • M729700580I0 ()
  • M729700580I3 ()

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


  • Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen
8-0 Suture USP / Thread Specifications: Silk, Black Braided, 12 inch (30 cm) / Needle Specifications: ST-140-8, Spatula Tip, 3/8 circle (140 degrees), length 6 mm, wire 0.20mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S84082
In Commercial Distribution

  • M583S840823 ()
  • M583S840822 ()
  • M583S840821 ()

  • Angle: 140 degree
  • 8-0 USP
  • Outer Diameter: 0.20 Millimeter
  • Length: 6.0 Millimeter
  • Length: 30 Centimeter


  • Silk suture
Mediastinal Drain, Silicone, Eyes On Top Bottom & Sides, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111009AT
In Commercial Distribution

  • M665111009AT3 ()
  • M665111009AT1 ()
  • M665111009AT0 ()

  • Lumen/Inner Diameter: 9 Millimeter


  • Mediastinal drainage catheter, non-antimicrobial
7-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 30 cm / Needle Specifications: TP-140-9, Taper Point Needle, 3/8 (140 degrees), length 6.00 mm, wire 0.23 mm / # of needles: Double Arm
VISIONARY MEDICAL SUPPLIES INC
N74092TP
In Commercial Distribution

  • M583N74092TP3 ()
  • M583N74092TP2 ()
  • M583N74092TP1 ()

  • Length: 30 Centimeter
  • Length: 6.00 Millimeter
  • Outer Diameter: 0.23 Millimeter
  • 7-0 USP
  • Angle: 140 degree


  • Nylon suture, non-bioabsorbable, monofilament
HA PEEK, Ta
Innovasis, Inc.
LXL26185516
In Commercial Distribution

  • M711LXL261855161 ()
  • M711LXL261855160 ()

  • Width: 26 Millimeter
  • Height: 18 Millimeter
  • Length: 55 Millimeter
  • Angle: 16 degree
LXL26185516

  • Polymeric spinal interbody fusion cage
HA PEEK, Ta
Innovasis, Inc.
LXL26185512
In Commercial Distribution

  • M711LXL261855121 ()
  • M711LXL261855120 ()

  • Width: 26 Millimeter
  • Height: 18 Millimeter
  • Length: 55 Millimeter
  • Angle: 12 degree
LXL26185512

  • Polymeric spinal interbody fusion cage
HA PEEK, Ta
Innovasis, Inc.
LXL26185508
In Commercial Distribution

  • M711LXL261855081 ()
  • M711LXL261855080 ()

  • Width: 26 Millimeter
  • Height: 18 Millimeter
  • Length: 55 Millimeter
  • Angle: 8 degree
LXL26185508

  • Polymeric spinal interbody fusion cage
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