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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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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
Wallmax Aneroid Sphygmomanometer
GF HEALTH PRODUCTS, INC.
V222B
In Commercial Distribution

  • M368V222B1 ()
  • M368V222B2 ()
  • M368V222B3 ()


  • Aneroid manual sphygmomanometer
TENS Electrodes
GF HEALTH PRODUCTS, INC.
9261
In Commercial Distribution

  • M36892613 ()
  • M36892612 ()
  • M36892611 ()


  • Transcutaneous electrical stimulation electrode, single-use
TENS Electrodes
GF HEALTH PRODUCTS, INC.
9260
In Commercial Distribution

  • M36892603 ()
  • M36892602 ()
  • M36892601 ()
  • M36892600 ()


  • Transcutaneous electrical stimulation electrode, single-use
Disposable Stethoscope
GF HEALTH PRODUCTS, INC.
722Y
In Commercial Distribution

  • M368722Y2 ()
  • M368722Y1 ()
  • M368722Y3 ()


  • Mechanical stethoscope
Disposable Stethoscope
GF HEALTH PRODUCTS, INC.
722B
In Commercial Distribution

  • M368722B2 ()
  • M368722B1 ()
  • M368722B3 ()


  • Mechanical stethoscope
Portable Ultrasonic Nebulizer
GF HEALTH PRODUCTS, INC.
6700
In Commercial Distribution

  • M36867003 ()
  • M36867002 ()
  • M36867001 ()


  • Benchtop nebulizer, non-heated
TRACLUX Light Carrier, Sterile, Single Use, and accessories
SUNOPTIC TECHNOLOGIES LLC
TLC
In Commercial Distribution

  • M678TLC0 ()
  • M678TLC1 ()
  • M678TLC3 ()
TLC2575, TLC25150, TLC1353-U

  • Open surgical site internal light
Battery powered light source for illumination of a surgical field.
SUNOPTIC TECHNOLOGIES LLC
ROVER SLS
In Commercial Distribution

  • M678SLSS0 ()
  • M678SLSS1 ()
  • M678SLSS3 ()
ROVER SLS-S

  • Open surgical site internal light
Closed Wound Drain, Round, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803643
In Commercial Distribution

  • M6658036433 ()
  • M6658036431 ()
  • M6658036430 ()

  • 15 FR


  • Closed-wound drain, non-bioabsorbable
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