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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. The Digital Breast Tomosynthesis imaging uses high-resolution Tomosynthesis, known as Clarity HD.
Hologic, Inc.
ASY-11748-CHD-CN
In Commercial Distribution

  • 15420045518056 ()
ASY-11748-CHD-CN

  • 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. The Digital Breast Tomosynthesis imaging uses high-resolution Tomosynthesis, known as Clarity HD.
Hologic, Inc.
ASY-11748-CHD
In Commercial Distribution

  • 15420045511897 ()
ASY-11748-CHD

  • Stationary mammographic x-ray system, digital
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Data Analysis Platform (CDAP) is a component of the Cordella Pulmonary Artery Sensor System. The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based, standalone application that collects and stores raw Reader data and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.
Endotronix, Inc.
100543-00
In Commercial Distribution

  • 00850008997051 ()


  • Implantable pulmonary artery pressure monitoring system
SILIKON™ 1000 (purified polydimethylsiloxane) is highly purified long chain polydimethylsiloxane trimethylsiloxy terminated silicone oil. It is sterile, non-pyrogenic, clear, colorless and has a viscosity of 1000 cs. for use as a post-operative retinal tamponade during vitreoretinal surgery. SILIKON™ 1000 is composed of silicon, oxygen, carbon and hydrogen atoms. SILIKON™ 1000 is immiscible with aqueous components and is relatively inert material with little biological toxicity potential.
Alcon Laboratories, Inc.
8065601187
In Commercial Distribution

  • 00380656011873 ()

  • Total Volume: 8.5 Milliliter


  • Aqueous/vitreous humour replacement medium kit
The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture.
Oxford Immunotec, Inc.
TSK.910
In Commercial Distribution

  • 05051716000186 ()
TSK.910US

  • T lymphocyte magnetic separation reagent IVD
VLV EVOLUTPRO-29-US PRO BLNK US
MEDTRONIC COREVALVE LLC
EVOLUTPRO-29-US
In Commercial Distribution

  • 00643169954458 ()

  • Valve Size 29 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
VLV EVOLUTPRO-26-US PRO BLNK US
MEDTRONIC COREVALVE LLC
EVOLUTPRO-26-US
In Commercial Distribution

  • 00643169954441 ()

  • Valve Size 26 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
VLV EVOLUTPRO-23-US PRO BLNK US
MEDTRONIC COREVALVE LLC
EVOLUTPRO-23-US
In Commercial Distribution

  • 00643169954434 ()

  • Valve Size 23 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CD3369-40Q
In Commercial Distribution

  • 05414734508377 ()
CD3369-40Q

  • Cardiac resynchronization therapy implantable defibrillator
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CD3369-40C
In Commercial Distribution

  • 05414734508346 ()
CD3369-40C

  • Cardiac resynchronization therapy implantable defibrillator
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