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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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A foldable posterior chamber intraocular lens (IOL) pre-loaded in an injector that automatically folds the lens as it is advanced, prior to insertion.
HOYA MEDICAL SINGAPORE PTE. LTD.
CLSRT (clear), + 9.00 D
In Commercial Distribution

  • 04547480600079 ()

  • Outer Diameter: 12.5 Millimeter


  • Posterior-chamber intraocular lens, pseudophakic
A foldable posterior chamber intraocular lens (IOL) pre-loaded in an injector that automatically folds the lens as it is advanced, prior to insertion.
HOYA MEDICAL SINGAPORE PTE. LTD.
CLSRT (clear), + 8.50 D
In Commercial Distribution

  • 04547480600062 ()

  • Outer Diameter: 12.5 Millimeter


  • Posterior-chamber intraocular lens, pseudophakic
A foldable posterior chamber intraocular lens (IOL) pre-loaded in an injector that automatically folds the lens as it is advanced, prior to insertion.
HOYA MEDICAL SINGAPORE PTE. LTD.
CLSRT (clear), + 8.00 D
In Commercial Distribution

  • 04547480600055 ()

  • Outer Diameter: 12.5 Millimeter


  • Posterior-chamber intraocular lens, pseudophakic
A foldable posterior chamber intraocular lens (IOL) pre-loaded in an injector that automatically folds the lens as it is advanced, prior to insertion.
HOYA MEDICAL SINGAPORE PTE. LTD.
CLSRT (clear), + 7.50 D
In Commercial Distribution

  • 04547480600048 ()

  • Outer Diameter: 12.5 Millimeter


  • Posterior-chamber intraocular lens, pseudophakic
A foldable posterior chamber intraocular lens (IOL) pre-loaded in an injector that automatically folds the lens as it is advanced, prior to insertion.
HOYA MEDICAL SINGAPORE PTE. LTD.
CLSRT (clear), + 7.00 D
In Commercial Distribution

  • 04547480600031 ()

  • Outer Diameter: 12.5 Millimeter


  • Posterior-chamber intraocular lens, pseudophakic
A foldable posterior chamber intraocular lens (IOL) pre-loaded in an injector that automatically folds the lens as it is advanced, prior to insertion.
HOYA MEDICAL SINGAPORE PTE. LTD.
CLSRT (clear), + 6.00 D
In Commercial Distribution

  • 04547480600017 ()

  • Outer Diameter: 12.5 Millimeter


  • Posterior-chamber intraocular lens, pseudophakic
HEMOBLAST Bellows Laparoscopic Applicator is intended for delivery of HEMOBLAST Bellows hemostatic powder to bleeding surgical sites through a 5mm or larger trocar.
DILON TECHNOLOGIES FRANCE
LAP01-US
In Commercial Distribution

  • 03760193182668 ()
  • 23760193182662 ()
  • 13760193182665 ()
LAP01-US

  • Collagen haemostatic agent, non-antimicrobial
neuro membrane for a FUS brain treatment to hold degassed water between transducer and skull. included in 3T Neuro kit for USA (SET000936)
INSIGHTEC LTD
neuro membrane
In Commercial Distribution

  • 07290015461177 ()
ASM000355

  • Therapeutic oncological/gynaecological ultrasound system
The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the Prometra pump.
Flowonix Medical, Inc.
11828
In Commercial Distribution

  • 00810335020129 ()


  • Infusion pump programmer
LungFit PH Product Description The LungFit PH System generates nitric oxide (NO) from room air and delivers it to a mechanical ventilator breathing circuit in a controlled concentration from 0.1 to 80 ppm NO. The attached nitric oxide delivery module (NDM) measures the gas flow in the ventilator breathing circuit and delivers a controlled flow of nitric oxide enriched gas into the breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the ventilator breathing circuit just prior to inhalation by the patient, via a sampling line. The system is comprised of three sub-systems: The NO Generator with the NO2 Filter, the Nitric Oxide Backup and Bagging System, and the Gas Sampling and Monitoring System.
Beyond Air, Inc.
90002
In Commercial Distribution

  • B882900020 ()


  • Nitric oxide delivery unit, system-based
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