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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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CAPILLAROSCOPE WITH PROFESSIONAL SW (500x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-319
Not in Commercial Distribution

  • B1623191 ()
FEDMEDMICFIT6SWC_US

  • Otoscope, direct
CAPILLAROSCOPE WITH PROFESSIONAL SW (5X-200x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-317
Not in Commercial Distribution

  • B1623171 ()
FEDMEDMICFISTDSWC_US

  • Otoscope, direct
DEMATOSCOPE WITH PROFESSIONAL SW (10X-90x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-316
Not in Commercial Distribution

  • B1623161 ()
FEDMEDMICFIUVWPSWD_US

  • Otoscope, direct
DEMATOSCOPE WITH PROFESSIONAL SW (5X-200x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-314
Not in Commercial Distribution

  • B1623141 ()
FEDMEDMICFIPSWD_US

  • Otoscope, direct
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
90126-100ML
In Commercial Distribution

  • 00810195240422 ()
90126

  • 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
No Description
Biomet Orthopedics, LLC
31-473621
In Commercial Distribution

  • 00887868480911 ()
31-473621

  • Surgical mallet
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
Content: 1 piece Height: 25 mm
ZIRKONZAHN SRL
ZROA0971
In Commercial Distribution

  • D800ZROA0971 ()


  • Dental appliance fabrication material, ceramic
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