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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 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
BEQ-HMOD 70000-USA Adult Quadrox iD, Blood Transfer Bag 600 ml,CDI Sat Cell 3/8" System 100, Gas Filter
DATASCOPE CORP.
BEQ-TOP 37500
Not in Commercial Distribution

  • 00607567212534 ()
701055601R01

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 30000-USA Pediatric Quadrox iD, Softshell Venous Reser. 800ml, Better Bladder 1/4, BMU Cell Ven. 1/4m, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8
DATASCOPE CORP.
BEQ-TOP 37302
Not in Commercial Distribution

  • 00607567207875 ()
701065190

  • Cardiopulmonary bypass system blood tubing set
BEQ-HMOD 70000-USA Adult Quadrox iD, Blood Transfer Bag 600 ml, CDI Sat Cell 3/8" System 100, Gas Filter.
DATASCOPE CORP.
BEQ-TOP 37500
Not in Commercial Distribution

  • 00607567204171 ()
701055601

  • Cardiopulmonary bypass system blood tubing set
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
6800-30-50844
In Commercial Distribution

  • 06944904006550 ()


  • Patient monitoring system module, multiple-gas
A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
190-000
Not in Commercial Distribution

  • 10811877011269 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
High Power Single-Use Laser Fiber
BOSTON SCIENTIFIC CORPORATION
M006R8403960
Not in Commercial Distribution

  • 08714729963844 ()
  • 08714729963837 ()

  • 242 um Diameter


  • General/multiple surgical laser system beam guide, single-use
No Description
Intersurgical Incorporated
STR/019
In Commercial Distribution

  • 08058323030831 ()
  • 08058323016606 ()


  • Straight/elbow breathing circuit connector, single-use
rapid ID 32 E is a standardized system for the identification of Enterobacteriaceae in 4 hours
BIOMERIEUX SA
RAPID ID 32 E
In Commercial Distribution

  • 03573026066574 ()
  • 03573026588649 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
rapid ID 32 STREP is a standardized system for the identification of streptococci and enterococci, and those most common related organisms, in 4 hours
BIOMERIEUX SA
RAPID ID 32 STREP
In Commercial Distribution

  • 03573026066536 ()
  • 03573026588625 ()


  • Multiple Streptococcus bacterial species culture isolate identification IVD, kit
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