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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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ONDAMED Biofeedback System with MA4
ONDAMED INC.
001-53-0101
In Commercial Distribution

  • 00852318007536 ()
001-53-0101

  • Biofeedback system
Earloop Mask with Ribbon Print
PRESTIGE AMERITECH, LTD.
FM85012
In Commercial Distribution

  • 00852212003573 ()
  • 80852212003579 ()


  • Surgical/medical face mask, single-use
M8MAS DRIVER WITH DRAIN HOLES
MEDTRONIC SOFAMOR DANEK, INC.
X0501002
In Commercial Distribution

  • 00721902043741 ()


  • Orthopaedic implant driver
NIBP Single tube with Connectors
Orantech Inc.
BPA-NS-01P-60
In Commercial Distribution

  • 06941691920540 ()


  • External cuff/pad connection tubing
HEPARIN NEEDLE WITH OLIVE TIP
TELEFLEX INCORPORATED
IPN018853
In Commercial Distribution

  • 54026704795562 ()
  • 14026704795564 ()
P18815

  • Vascular irrigation cannula, coronary artery, reusable
AU680 Chemistry Analyzer (with ISE)
Beckman Coulter, Inc.
B96696
In Commercial Distribution

  • 14987666543009 ()


  • Multiple clinical chemistry analyser IVD, laboratory
AU480 Chemistry Analyzer (with ISE)
Beckman Coulter, Inc.
B96693
In Commercial Distribution

  • 14987666542972 ()


  • Multiple clinical chemistry analyser IVD, laboratory
ChlorCid with Surfactant Bottle 16oz
ULTRADENT PRODUCTS, INC.
4613
In Commercial Distribution

  • 00883205021557 ()
4613

  • Endodontic reaming aid material
ChlorCid with Surfactant IndiSpense Refill
ULTRADENT PRODUCTS, INC.
97
In Commercial Distribution

  • 00883205021540 ()
97

  • Endodontic reaming aid material
Orthex Strut Diagonal with QC
VILEX IN TENNESSEE, INC.
390-045-Q
In Commercial Distribution

  • 00841731114747 ()


  • External orthopaedic fixation system, single-use
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