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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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APIFIX LTD
Screw 5.0 X 35
In Commercial Distribution

  • 07290018128060 ()


  • Spinal bone screw, non-bioabsorbable
No Description
APIFIX LTD
Screw 5.0 X 30
In Commercial Distribution

  • 07290018128053 ()


  • Spinal bone screw, non-bioabsorbable
The HPX Polarization Measurement Station is a low-field nuclear magnetic resonance (NMR) spectrometer tuned to detect xenon Xe 129 signal. The HPX Polarization Measurement Station accomplishes the following: Ensures that the amount of XENOVIEW™ in the XENOVIEW™ Dose Delivery Bag is sufficient for measurement; Calculates the Dose Equivalent (DE) value prior to administration to a patient; Stores a XENOVIEW™ Dose Delivery Bag filled with XENOVIEW™ in a static magnetic field.
Polarean, Inc.
Rev. D
In Commercial Distribution

  • 00850045949020 ()
42881

  • Lung MRI xenon hyperpolarization system
SPINE PACK
Cardinal Health 200, LLC
SNE48LMCO4
In Commercial Distribution

  • 50197106832613 ()
  • 10197106832615 ()
SNE48LMCO4

  • Ice bag
The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
MESA BIOTECH, INC.
COV4100
In Commercial Distribution

  • B540COV41000 ()
COV4100

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
A package of 10 x UroShield disposable Actuators The UroShield is a single catheter use accessory that is clipped on the catheter's external part. After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
NANOVIBRONIX INC.
3.0 Actuator
In Commercial Distribution

  • 07290103420123 ()
10-200-0002

  • Urinary catheter ultrasonic bacterial adhesion inhibition system actuator
The UroShield disposable Actuator is a single catheter use accessory that is clipped on the catheter's external part. After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
NANOVIBRONIX INC.
3.0 actuator
In Commercial Distribution

  • 07290103420116 ()
10-600-0003

  • Urinary catheter ultrasonic bacterial adhesion inhibition system actuator
Dretler Ureteroscopy Stent Set
COOK INCORPORATED
G15168
In Commercial Distribution

  • 00827002151680 ()
025508

  • Polymeric ureteral stent
Dretler Ureteroscopy Stent Set
COOK INCORPORATED
G15110
In Commercial Distribution

  • 00827002151109 ()
025506

  • Polymeric ureteral stent
Dretler Ureteroscopy Stent Set
COOK INCORPORATED
G14514
In Commercial Distribution

  • 00827002145146 ()
025505

  • Polymeric ureteral stent
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