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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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Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 Pair
Biodermis LLC
ELP-1
In Commercial Distribution

  • 00852260000937 ()
ELP-1

  • Scar-management dressing, reusable
3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIRE & 22GA NEEDLENEEDLE
Medical Components, Inc.
DMR1903422
In Commercial Distribution

  • 30884908145473 ()
  • 00884908145472 ()
  • 50884908145477 ()
DMR1903422

  • Vascular catheter introduction needle
3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIRE & 22GA NEEDLENEEDLE
Medical Components, Inc.
DMR1903222
In Commercial Distribution

  • 50884908145446 ()
  • 30884908145442 ()
  • 00884908145441 ()
DMR1903222

  • Vascular catheter introduction needle
2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIRE & 22GA NEEDLENEEDLE
Medical Components, Inc.
DMR1902422
In Commercial Distribution

  • 50884908144357 ()
  • 30884908144353 ()
  • 00884908144352 ()
DMR1902422

  • Vascular catheter introduction needle
2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIRE & 22GA NEEDLENEEDLE
Medical Components, Inc.
DMR1902222
In Commercial Distribution

  • 30884908144322 ()
  • 00884908144321 ()
  • 50884908144326 ()
DMR1902222

  • Vascular catheter introduction needle
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
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
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