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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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Anti-HBc EIA, Conjugate Reagent 30 mL
Bio-RAD Laboratories, Inc.
26193
In Commercial Distribution

  • 00847865013079 ()

  • Total Volume: 30 Milliliter
26193

  • Hepatitis B virus core antigen IVD, reagent
Anti-HBc EIA, Specimen Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26196
In Commercial Distribution

  • 00847865013109 ()

  • Total Volume: 30 Milliliter
26196

  • Hepatitis B virus core antigen IVD, reagent
Complexed Prostate Specific Antigen (cPSA) Pretreatment - Atellica IM - CONS (1PK) 1 x 5mL
Siemens Healthcare Diagnostics Inc.
10995546
In Commercial Distribution

  • 00630414598703 ()
10995546

  • Complexed prostate specific antigen (cPSA) IVD, reagent
The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will be tested using the Alere NMP22® (ELISA)Test Kit .
Alere Scarborough, Inc.
D2100E
In Commercial Distribution

  • 10811877010637 ()


  • Nuclear matrix protein 22 IVD, reagent
EDWARDS INTUITY ELITE VALVE SYSTEM
Edwards Lifesciences LLC
8300KITB27
In Commercial Distribution

  • 00690103194562 ()

  • VALVE STENT DIAMETER, 27 MM
8300KITB27A

  • Cardiac valvuloplasty catheter
  • Aortic open-surgery heart valve bioprosthesis
EDWARDS INTUITY ELITE VALVE SYSTEM
Edwards Lifesciences LLC
8300KITB25
In Commercial Distribution

  • 00690103194555 ()

  • VALVE STENT DIAMETER, 25 MM
8300KITB25A

  • Cardiac valvuloplasty catheter
  • Aortic open-surgery heart valve bioprosthesis
EDWARDS INTUITY ELITE VALVE SYSTEM
Edwards Lifesciences LLC
8300KITB23
In Commercial Distribution

  • 00690103194548 ()

  • VALVE STENT DIAMETER, 23 MM
8300KITB23A

  • Cardiac valvuloplasty catheter
  • Aortic open-surgery heart valve bioprosthesis
EDWARDS INTUITY ELITE VALVE SYSTEM
Edwards Lifesciences LLC
8300KITB21
In Commercial Distribution

  • 00690103194531 ()

  • VALVE STENT DIAMETER, 21 MM
8300KITB21A

  • Cardiac valvuloplasty catheter
  • Aortic open-surgery heart valve bioprosthesis
EDWARDS INTUITY ELITE VALVE SYSTEM
Edwards Lifesciences LLC
8300KITB19
In Commercial Distribution

  • 00690103194524 ()

  • VALVE STENT DIAMETER, 19 MM
8300KITB19A

  • Cardiac valvuloplasty catheter
  • Aortic open-surgery heart valve bioprosthesis
No Description
SALUDA MEDICAL PTY LIMITED
3036
In Commercial Distribution

  • 09352307000346 ()
3036

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
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