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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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BD PrepStain Slide Processor - 00382904901004

BD PrepStain® Slide Processor transfers cell samples from the specimen tubes to settling chambers mounted to microscope slides. The instrument then automatically stains and rinses each slide
BECTON, DICKINSON AND COMPANY
490100
In Commercial Distribution

  • 00382904901004 ()

  • Depth: 25 Inch
  • Width: 40 Inch
  • Height: 34 Inch
490100

  • Microscope slide maker/stainer IVD

SULFLUX - 04537693900639

Indications for FH: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KP-05
In Commercial Distribution

  • 14537693900636 ()
  • 04537693900639 ()


  • Apheresis system filter, whole blood

HiRes 90K™ Advantage CI HiFocus™ MS Electrode - 07630016828638

No Description
Advanced Bionics AG
CI-1500-04
Not in Commercial Distribution

  • 07630016828638 ()


  • Cochlear implant system electrode array assembly

HiFocus™ MS Electrode Insertion Tool Kit - 07630016828621

No Description
Advanced Bionics, LLC
CI-4507
Not in Commercial Distribution

  • 07630016828621 ()


  • Cochlear implant system

HiRes 90K Helix Insertion Tool Kit - 07630016810046

No Description
Advanced Bionics, LLC
CI-4506
Not in Commercial Distribution

  • 07630016810046 ()


  • Cochlear implant system

HiFocus™ MS Electrode Insertion Tool Kit - 07630016816819

No Description
Advanced Bionics, LLC
CI-4507
Not in Commercial Distribution

  • 07630016816819 ()


  • Cochlear implant system

HiRes 90K™ CI HiFocus Helix™ Electrode - 07630016816260

No Description
Advanced Bionics AG
CI-1400-02H
Not in Commercial Distribution

  • 07630016816260 ()


  • Cochlear implant system electrode array assembly

HiRes 90K™ CI HiFocus™ 1j Electrode - 07630016816253

No Description
Advanced Bionics AG
CI-1400-01
Not in Commercial Distribution

  • 07630016816253 ()


  • Cochlear implant system electrode array assembly

HiRes 90K™ Advantage CI HiFocus Helix™ Electrode - 07630016815812

No Description
Advanced Bionics AG
CI-1500-02H
Not in Commercial Distribution

  • 07630016815812 ()


  • Cochlear implant system electrode array assembly

HiRes 90K™ Advantage CI HiFocus™ 1j Electrode - 07630016815805

No Description
Advanced Bionics AG
CI-1500-01
Not in Commercial Distribution

  • 07630016815805 ()


  • Cochlear implant system electrode array assembly
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