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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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No Description
Drägerwerk AG & Co. KGaA
MP01325
Not in Commercial Distribution

  • 04048675248507 ()
  • 04048675421542 ()


  • Ventilator breathing circuit, single-use
A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in anterior nasal swab and nasopharyngeal swab specimens.
Alere Scarborough, Inc.
192-000
In Commercial Distribution

  • 00811877011354 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.
Alere Scarborough, Inc.
EQ00200XS
In Commercial Distribution

  • 00811877010616 ()


  • Isothermal nucleic acid amplification analyser IVD, laboratory
The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.
Alere Scarborough, Inc.
EQ00200X
In Commercial Distribution

  • 00811877010593 ()


  • Isothermal nucleic acid amplification analyser IVD, laboratory
No Description
ACCUTRON, INC.
23126
Not in Commercial Distribution

  • 00813830020106 ()
23126

  • Medical gas pipeline system
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
Round 27.23 mm ID x 30.18mm OD
WESTMED, INC.
6901-1R
In Commercial Distribution

  • 10709078001755 ()
  • 00709078001758 ()


  • Pulmonary function testing filter/mouthpiece
Eliptical 27.23 mm ID x 30.18mm OD
WESTMED, INC.
6901-1E
In Commercial Distribution

  • 10709078001748 ()
  • 00709078001741 ()


  • Pulmonary function testing filter/mouthpiece
BASE 27106 SNAP ASSY W/LARGER ID
MEDTRONIC PS MEDICAL, INC.
27106
In Commercial Distribution

  • 00643169498174 ()

  • Width: 6.0 Millimeter


  • Cranial port/reservoir
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