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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

Tip with Indexable Stop - 08057639710574

Tip with Indexable Stop for MCBio Tacks
MC BIO SRL
9570566
In Commercial Distribution

  • 08057639710574 ()


  • Bone tack inserter, basic

Nitrile PF with Aloe - 00649531320777

Nitrile Exam Glove with Aloe, Green, X-Large
Dash Medical Gloves, Inc.
NA100XL
In Commercial Distribution

  • 00649531420774 ()
  • 00649531320777 ()
  • 00649531320074 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nitrile PF with Aloe - 00649531320760

Nitrile Exam Glove with Aloe, Green, Large
Dash Medical Gloves, Inc.
NA100L
In Commercial Distribution

  • 00649531420767 ()
  • 00649531320760 ()
  • 00649531320067 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nitrile PF with Aloe - 00649531320746

Nitrile Exam Glove with Aloe, Green, Medium
Dash Medical Gloves, Inc.
NA100M
In Commercial Distribution

  • 00649531420743 ()
  • 00649531320746 ()
  • 00649531320043 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nitrile PF with Aloe - 00649531320722

Nitrile Exam Glove with Aloe, Green, Small
Dash Medical Gloves, Inc.
NA100S
In Commercial Distribution

  • 00649531420729 ()
  • 00649531320722 ()
  • 00649531320029 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

ExuCare Small with foot - 00850051939473

A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.
SUN SCIENTIFIC, INC.
EC6150
In Commercial Distribution

  • 00850051939473 ()
ECWF100

  • First aid absorbent pad/bandage

ExuCare Large with foot - 00850051939381

A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.
SUN SCIENTIFIC, INC.
EC6350
In Commercial Distribution

  • 00850051939381 ()
ECWF300

  • First aid absorbent pad/bandage

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

Otoport - Screener with ABR - 05060396171062

No Description
OTODYNAMICS LIMITED
OS-ST+ABR
In Commercial Distribution

  • 05060396171062 ()


  • Evoked-potential audiometer
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