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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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RANFAC BREAST MRK, 10CM F/G SBS-10 PN 60004-02M
RANFAC CORP.
10CM
In Commercial Distribution

  • M9796000402M9 ()
  • M9796000402M1 ()
  • M9796000402M0 ()

  • Length: 10 Centimeter
SBS-10

  • Needle guide, single-use
RANFAC BREAST MRK, 5CM F/G SBS-5 PN 60004-01M
RANFAC CORP.
5CM
In Commercial Distribution

  • M9796000401M9 ()
  • M9796000401M1 ()
  • M9796000401M0 ()

  • Length: 5 Centimeter
SBS-5

  • Needle guide, single-use
No Description
BIOTEX, INC.
SL-12
In Commercial Distribution

  • M710SL122 ()
  • M710SL120 ()
  • M710SL124 ()
SL-12

  • Operating room light
Smoke Aspiration Tip
IMPLANTECH ASSOCIATES, INC.
SE-100
In Commercial Distribution

  • M724SE100102 ()
  • M724SE1001 ()
  • M724SE100252 ()
SE-100

  • Surgical plume evacuation system tube
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
Dressing Change Tray
STRADIS MEDICAL LLC
IM1256
In Commercial Distribution

  • M752IM12665 ()
  • M752IM12560 ()
  • M752IM12565 ()


  • Wound dressing kit, non-medicated
Dressing Change Tray W/ Biopatch
STRADIS MEDICAL, LLC
HCT9948BP
Not in Commercial Distribution

  • M752HCT9948BP5 ()
  • M752HCT9948BP0 ()
  • M752HCT9948BP6 ()


  • Wound dressing kit, medicated
5CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT5CC-LL
In Commercial Distribution

  • M752HCT5CCLL0 ()
  • M752HCT5CCLL5 ()
  • M752HCT5CCLL1 ()


  • General-purpose syringe, single-use
10CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT10CC-LL
In Commercial Distribution

  • M752HCT10CCLL5 ()
  • M752HCT10CCLL1 ()
  • M752HCT10CCLL0 ()


  • General-purpose syringe, single-use
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