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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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Cochlear Nucleus Freedom Implant with Contour Advance Electrode
COCHLEAR LIMITED
Z60353
In Commercial Distribution

  • 09321502007320 ()
Z60353

  • Cochlear implant system electrode array assembly
SurePath® GYN Preservative Vial Kit with Cervex-Brush
BECTON, DICKINSON AND COMPANY
491095
Not in Commercial Distribution

  • 00382904910952 ()

  • Height: 37 Inch
  • Width: 44 Centimeter
  • Length: 44 Centimeter
491095

  • Endocervical specimen cytological examination kit IVD
Polarized Defibrillation Pads(adult) with two-year shelf life
Zoll Medical Corporation
9660-001
In Commercial Distribution

9660-001

  • Multifunction cardiac electrode
Polarized Defibrillation Pads(adult) with two-year shelf life
Cardiac Science Corporation
9660-001
In Commercial Distribution

  • 00812394020249 ()
9660-001

  • Multifunction cardiac electrode
Impella 5.5 with Smart Assist S2 Set, US
Abiomed, Inc.
1000100
In Commercial Distribution

  • 00813502012828 ()
1000100

  • Intracardiac circulatory assist axial-pump catheter
Blue Lead Kit, 70cm with 5mm Spacing, Downsized
NEVRO CORP.
TLEAD1058-70B
In Commercial Distribution

  • 00813426021104 ()


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Blue Lead Kit, 50cm with 5mm Spacing, Downsized
NEVRO CORP.
TLEAD1058-50B
In Commercial Distribution

  • 00813426021098 ()


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Left Atrial Appendage Closure Device with Delivery System
BOSTON SCIENTIFIC CORPORATION
M635WU50310
In Commercial Distribution

  • 08714729860518 ()

  • Outer Diameter: 31 Millimeter
M635WU50310

  • Cardiac defect occluder
Left Atrial Appendage Closure Device with Delivery System
BOSTON SCIENTIFIC CORPORATION
M635WU50240
In Commercial Distribution

  • 08714729860495 ()

  • Outer Diameter: 24 Millimeter
M635WU50240

  • Cardiac defect occluder
PRDS-USG-2X Paradise® Generator with Paradise® Remote
Recor Medical, Inc.
PRDS-USG-2X
In Commercial Distribution

  • 00810008950128 ()
PRDS-USG-2X

  • Renal denervation ultrasound system generator
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