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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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Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
CL-R-CT
Not in Commercial Distribution

  • B056CLRCT2 ()
  • B056CLRCT1 ()
  • B056CLRCT0 ()
  • B056CLRCT5 ()
CL-R-CT

  • Assisted reproduction vitrification carrier
CryoPRO™-5 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0442
In Commercial Distribution

  • B039SGI04421 ()
  • B039SGI04420 ()
  • B039SGI04429 ()


  • Blood cell freeze/thaw system
SynGenX®-1000 Disposable Cartridge
Thermogenesis Corp.
SGI-0305
In Commercial Distribution

  • B039SGI03050 ()
  • B039SGI03051 ()
  • B039SGI03059 ()


  • Umbilical cord blood collection set
CryoPRO™-2 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0091
In Commercial Distribution

  • B039SGI00911 ()
  • B039SGI00910 ()
  • B039SGI00919 ()


  • Blood cell freeze/thaw system
Disposable Bipolar Cord Straight 12 FT
STINGRAY SURGICAL PRODUCTS, LLC
S04-800
Not in Commercial Distribution

  • B112S048000 ()
  • B112S048001 ()
  • B112S048002 ()


  • Electrical-only medical device connection cable, single-use
The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 235 cm.
SLATER ENDOSCOPY LLC
ES26235
In Commercial Distribution

  • M707ES26235 ()
  • M707ES262351 ()
  • M707ES262350 ()

  • Length: 235 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26235

  • Flexible endoscopic scissors, single-use
The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 165 cm.
SLATER ENDOSCOPY LLC
ES26165
In Commercial Distribution

  • M707ES26165 ()
  • M707ES261651 ()
  • M707ES261650 ()

  • Length: 165 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26165

  • Flexible endoscopic scissors, 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
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