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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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Prime ES Plus
NOVA BIOMEDICAL CORPORATION
Prime ES Plus
In Commercial Distribution

  • 10385480623381 ()
  • 00385480623384 ()
62338

  • Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
Prime Sensor Card ES Comp Plus
NOVA BIOMEDICAL CORPORATION
Prime ES Comp Plus
In Commercial Distribution

  • 10385480614549 ()
  • 00385480614542 ()
61454

  • Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
Prime Sensor Card ES Plus
NOVA BIOMEDICAL CORPORATION
Prime ES Plus
In Commercial Distribution

  • 10385480614532 ()
  • 00385480614535 ()
61453

  • Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
Mago 4S Anayzer
DIAMEDIX CORPORATION
MAGO 4S
In Commercial Distribution

  • 00817273020471 ()


  • Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
MAGO Plus chemistry analyzer
DIAMEDIX CORPORATION
MAGO Plus
In Commercial Distribution

  • 00817273020464 ()


  • Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGPV00
In Commercial Distribution

  • 00877234000447 ()

  • Internal Diameter: Ranges from 6mm to 32mm (allograft specific)
SGPV00

  • Cadaveric heart valve prosthesis, decellularized, non-sterile
Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGPV10
In Commercial Distribution

  • 00877234000454 ()

  • Internal Diameter: Ranges from 6mm to 32mm (allograft specific)
SGPV10

  • Cadaveric heart valve prosthesis, decellularized, non-sterile
5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm Fiber Connect (UHMWPE)
DUNAMIS MEDICAL, LLC
DFX0040A
In Commercial Distribution

  • 00854629006321 ()
DFX0040A

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY
AULISA MEDICAL USA, INC.
GA2000Rx-P
In Commercial Distribution

  • 14719872650208 ()
  • 04719872650201 ()


  • Pulse oximetry telemetric monitoring system
Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY
AULISA MEDICAL USA, INC.
GA2000Rx-A
In Commercial Distribution

  • 14719872650192 ()
  • 04719872650195 ()


  • Pulse oximetry telemetric monitoring system
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