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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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Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-INTL2D-NS
In Commercial Distribution

  • 15420045510586 ()
3DM-SYS-INTL2D-NS

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-INTL3D
In Commercial Distribution

  • 15420045510579 ()
3DM-SYS-INTL3D

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-INTL3D-NS
In Commercial Distribution

  • 15420045510555 ()
3DM-SYS-INTL3D-NS

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-STD-NS
In Commercial Distribution

  • 15420045510548 ()
3DM-SYS-STD-NS

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
3DM-SYS-STD
In Commercial Distribution

  • 15420045510524 ()
3DM-SYS-STD

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
ASY-10636-2D
Not in Commercial Distribution

  • 15420045508026 ()
ASY-10636-2D

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
ASY-10559
In Commercial Distribution

  • 15420045508019 ()
ASY-10559

  • Stationary mammographic x-ray system, digital
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146_US
In Commercial Distribution

  • 05060462240043 ()


  • Liver donor-organ preservation/transport system
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0003
In Commercial Distribution

  • 05060462240005 ()


  • Liver donor-organ preservation/transport system
GenVisc® 850 sodium hyaluronate (P140005) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. GenVisc 850 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. GenVisc 850 is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).
Avanos Medical, Inc.
50653-0006-01
In Commercial Distribution

  • 10850653006013 ()
  • 00850653006016 ()
  • 20850653006010 ()


  • Synovial fluid supplementation medium
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