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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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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
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
CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129254 ()

  • 32 cm-42 cm ID
016-0077-06Q

  • Blood pressure ambulatory recorder
CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129247 ()

  • 12-20 cm/5-8in ID
015-0118-05Q

  • Blood pressure ambulatory recorder
CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129230 ()

  • 24-32 cm/ 9-13 " ID
015-0068-06Q

  • Blood pressure ambulatory recorder
CUFF,ABP,ADULT,S,17-26CM/7-10IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129223 ()

  • 28 cm/ 7-10" ID
015-0067-05Q

  • Blood pressure ambulatory recorder
ABP CUFF,SPACELABS,1T,XLADULT,SPU,20/BX
Statcorp Medical
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522123870 ()

  • 42 cm-50 cm ID
015-4250-00

  • Blood pressure cuff, single-use
XPE cup liner trial, ID 36mm, 0°x70mm
UNITED ORTHOPEDIC CORP.
1403-2770
In Commercial Distribution

  • 04719872161516 ()

  • ID 36mm, 0°x70mm
1403-2770

  • Acetabulum prosthesis trial, prefabricated, reusable
XPE cup liner trial, ID 36mm, 0°x68mm
UNITED ORTHOPEDIC CORP.
1403-2768
In Commercial Distribution

  • 04719872161509 ()

  • ID 36mm, 0°x68mm
1403-2768

  • Acetabulum prosthesis trial, prefabricated, reusable
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