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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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Alpine BioMed - 00885074291598

KEYPOINT WORKST NL
Alpine Biomed ApS
9031A006405
Not in Commercial Distribution

  • 00885074291598 ()


  • Electromyograph

Alpine BioMed - 00885074291574

KEYPOINT WORKST SP
Alpine Biomed ApS
9031A006404
Not in Commercial Distribution

  • 00885074291574 ()


  • Electromyograph

Alpine BioMed - 00885074291567

G3 KEYPOINT WORKSTATION GE
Alpine Biomed ApS
9031A006403
Not in Commercial Distribution

  • 00885074291567 ()


  • Electromyograph

Alpine BioMed - 00885074291529

KEYPOINT WORKST FR
Alpine Biomed ApS
9031A006402
Not in Commercial Distribution

  • 00885074291529 ()


  • Electromyograph

Alpine BioMed - 00885074291499

KEYPOINT WORKST UK
Alpine Biomed ApS
9031A006401
Not in Commercial Distribution

  • 00885074291499 ()


  • Electromyograph

Clear Guide CORE - B201CGCORE170

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-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer

cable - 00690103206951

ACUMEN AFM CABLE
Edwards Lifesciences LLC
AAFMC
In Commercial Distribution

  • 00690103206951 ()
AAFMC

  • General-purpose multi-parameter bedside monitor

Acumen IQ Sensor with Vamp with TruWave - 00690103205831

ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP WITH TRUWAVE 5-PACK
Edwards Lifesciences LLC
AIQSFM6C502
In Commercial Distribution

  • 50690103205836 ()
  • 00690103205831 ()
AIQSFM6C502

  • Intravenous line sensor, gravity infusion

ACUMEN IQ - 00690103205824

Acumen IQ Fluid Meter
Edwards Lifesciences LLC
AIQFM10
In Commercial Distribution

  • 50690103205829 ()
  • 00690103205824 ()
AIQFM10

  • Intravenous line sensor, gravity infusion

Acumen IQ Fluid Meter - 00690103205817

Acumen IQ Fluid Meter
Edwards Lifesciences LLC
AIQFM
In Commercial Distribution

  • 00690103205817 ()
AIQFM

  • Intravenous line sensor, gravity infusion
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