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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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Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System
PLASMA SURGICAL, INC
S2-CDU-7H
In Commercial Distribution

  • M397S2CDU7H0 ()
  • M397S2CDU7H2 ()
  • M397S2CDU7H9 ()

  • Length: 7 Centimeter
S2-CDU-7H

  • Plasma surgical system handpiece
Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System
PLASMA SURGICAL, INC
S2-CDU-7
In Commercial Distribution

  • M397S2CDU72 ()
  • M397S2CDU70 ()
  • M397S2CDU79 ()

  • Length: 7 Centimeter
S2-CDU-7

  • Plasma surgical system handpiece
Single-Use Cut\Coagulation Handpiece for Laparoscopic Surgical for the PlasmaJet System
PLASMA SURGICAL, INC
S2-CDU-28H
In Commercial Distribution

  • M397S2CDU28H2 ()
  • M397S2CDU28H0 ()
  • M397S2CDU28H9 ()

  • Length: 28 Centimeter
S2-CDU-28H

  • Plasma surgical system handpiece
Single-Use Cut\Coagulation Handpiece for Laparoscopic Surgical for the PlasmaJet System
PLASMA SURGICAL, INC
S2-CDU-28
In Commercial Distribution

  • M397S2CDU282 ()
  • M397S2CDU280 ()
  • M397S2CDU289 ()

  • Length: 28 Centimeter
S2-CDU-28

  • Plasma surgical system handpiece
Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System
PLASMA SURGICAL, INC
S2-CDU-12H
In Commercial Distribution

  • M397S2CDU12H0 ()
  • M397S2CDU12H2 ()
  • M397S2CDU12H9 ()

  • Length: 12 Centimeter
S2-CDU-12H

  • Plasma surgical system handpiece
Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System
PLASMA SURGICAL, INC
S2-CDU-12
In Commercial Distribution

  • M397S2CDU122 ()
  • M397S2CDU120 ()
  • M397S2CDU129 ()

  • Length: 12 Centimeter
S2-CDU-12

  • Plasma surgical system handpiece
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
8001 Series Foley Catheter Temperature Probe, 16 FR
MEASUREMENT SPECIALTIES, INC.
8001-063-416
In Commercial Distribution

  • H29780010634160 ()
  • H29780010634161 ()
  • H29780010634162 ()

  • Catheter Gauge: 16 French
8001-063-416

  • General-purpose patient temperature probe, single-use
8001 Series Foley Catheter Temperature Probe, 14 FR
MEASUREMENT SPECIALTIES, INC.
8001-063-414
In Commercial Distribution

  • H29780010634142 ()
  • H29780010634141 ()
  • H29780010634140 ()

  • Catheter Gauge: 14 French
8001-063-414

  • General-purpose patient temperature probe, single-use
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