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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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iReveal with PowerLook AMP - 00858012005656

PowerLook Density Assessment software application intended for use with digital mammography systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. PowerLook Density Assessment provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or diagnostic aid.
Icad, Inc.
V2.1
In Commercial Distribution

  • 00858012005656 ()
DSC012

  • Basic diagnostic x-ray system application software

Tri-Seal mouthseal with mouthpiece - 00850644007589

blue vinyl, 22mm OD, 50/bx
Vacumed
1007-MP
In Commercial Distribution

  • 00850644007589 ()
  • 08506440075896 ()
1007-MP

  • Breathing mouthpiece, single-use

Inspirachamber with InspiraMask (Large) - 00852367007013

InspiraChamber Anti-Static Valved Holding Chamber with InspiraMask- Hospital Unit
INSPIRX, INC
IC-IML-0
In Commercial Distribution

  • 00852367007013 ()
  • 10852367007010 ()


  • Medicine chamber spacer, reusable

AP70(with long antenna) - 06936415973537

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-071010-00
In Commercial Distribution

  • 06936415973537 ()


  • General-purpose multi-parameter bedside monitor

TOGGLELOC XL WITH ZIPLOOP - 00880304567641

No Description
Biomet Orthopedics, LLC
110005089
In Commercial Distribution

  • 00880304567641 ()
110005089

  • Ligament bone anchor

Cobalt HV with Gentamicin - 00880304560796

No Description
Biomet Orthopedics, LLC
402283
In Commercial Distribution

  • 00880304560796 ()
402283

  • Orthopaedic cement, antimicrobial

ToggleLoc With Ziploop Inline - 00880304567634

No Description
Biomet Orthopedics, LLC
110005087
In Commercial Distribution

  • 00880304567634 ()
110005087

  • Tendon/ligament bone anchor, non-bioabsorbable

Cobalt MV with Gentamicin - 00880304476783

No Description
Biomet Orthopedics, LLC
402439
In Commercial Distribution

  • 00880304476783 ()
402439

  • Orthopaedic cement, antimicrobial

Assistant with StableSoft 2S - 00699753450530

No Description
Terumo Cardiovascular Systems Corporation
45053
In Commercial Distribution

  • 50699753450535 ()
  • 00699753450530 ()


  • Cardiopulmonary bypass system blood tubing set

Assistant with StableSoft 2L - 00699753450523

No Description
Terumo Cardiovascular Systems Corporation
45052
In Commercial Distribution

  • 50699753450528 ()
  • 00699753450523 ()


  • Cardiopulmonary bypass system blood tubing set
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