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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 dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.
Sanuwave, Inc.
DEP0330/DAP0332
In Commercial Distribution

  • 00812265010225 ()


  • Dermatological extracorporeal shock wave therapy system
Modified HTF Medium with Human Serum Albumin (HSA). 100mL bottle.
IRVINE SCIENTIFIC, LLC
9983-100ML
In Commercial Distribution

  • 00810195240170 ()
9983

  • IVF medium
Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 10% (w/v) solution. Contains 5 mg/mL Human Serum Albumin.
IRVINE SCIENTIFIC, LLC
90123-5x0.5ML
In Commercial Distribution

  • 00810195240132 ()
90123

  • IVF medium
Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 7% (w/v) solution. Contains 5 mg/mL Human Serum Albumin.
IRVINE SCIENTIFIC, LLC
90121-5x0.5ML
In Commercial Distribution

  • 00810195240125 ()
90121

  • IVF medium
Modified HTF Medium with Human Serum Albumin (HSA). 500mL bottle.
IRVINE SCIENTIFIC, LLC
9983-500ML
In Commercial Distribution

  • 00810195240804 ()
9983

  • IVF medium
CHANG Medium D with Gentamicin for Human Amniotic Fluid Cells. 100mL bottle.
IRVINE SCIENTIFIC, LLC
99404-100ML
In Commercial Distribution

  • 00810195240583 ()
99404

  • Cell culture medium IVD
Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement.
IRVINE SCIENTIFIC, LLC
90126-500ML
In Commercial Distribution

  • 00810195240439 ()
90126

  • IVF medium
Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement.
IRVINE SCIENTIFIC, LLC
90126-100ML
In Commercial Distribution

  • 00810195240422 ()
90126

  • IVF medium
LOCATOR Abutment for RePlant 5.0mmD x 5.0mm
Zest Anchors, LLC
08770
In Commercial Distribution

  • 00840481134456 ()

  • Length: 5 Millimeter
08770-ID-SB

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for RePlant 5.0mmD x 4.0mm
Zest Anchors, LLC
08769
In Commercial Distribution

  • 00840481134449 ()

  • Length: 4 Millimeter
08769-ID-SB

  • Dental implant suprastructure, permanent, preformed
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