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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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Indigo System - 00810169721186

CAT6X w/Sonic + Lightning Bolt
PENUMBRA, INC.
LITNGBT6XTX-A
In Commercial Distribution

  • 00810169721186 ()


  • Thrombectomy suction catheter
  • Thrombectomy aspiration management software

Indigo System - 00810169720035

CAT12 115 HTORQ plus Lightning Bolt Aspiration Tubing, no CE
PENUMBRA, INC.
LITNGFB12HT115-A
In Commercial Distribution

  • 00810169720035 ()


  • Thrombectomy suction catheter
  • Thrombectomy aspiration management software

Indigo System - 00810169720028

CAT12 115 XTORQ plus Lightning Bolt Aspiration Tubing, no CE
PENUMBRA, INC.
LITNGFB12XT115-A
In Commercial Distribution

  • 00810169720028 ()


  • Thrombectomy suction catheter
  • Thrombectomy aspiration management software

Indigo System - 00810169720011

CAT12 100 HTORQ plus Lightning Bolt Aspiration Tubing, no CE
PENUMBRA, INC.
LITNGFB12HT100-A
In Commercial Distribution

  • 00810169720011 ()


  • Thrombectomy suction catheter
  • Thrombectomy aspiration management software

Indigo System - 00810169720004

CAT12 100 XTORQ plus Lightning Bolt Aspiration Tubing, no CE
PENUMBRA, INC.
LITNGFB12XT100-A
In Commercial Distribution

  • 00810169720004 ()


  • Thrombectomy suction catheter
  • Thrombectomy aspiration management software

ACUMEN IQ SENSOR FOR AFM - 00690103201062

ACUMEN IQ 84" / 213CM FOR USE WITH ASSISTED FLUID MANAGEMENT SOFTWARE FEATURE RED CAP FIVE PACK
Edwards Lifesciences LLC
AIQSAFM8R5
In Commercial Distribution

  • 50690103201067 ()
  • 00690103201062 ()

  • Length: 84.0000 Inch
AIQSAFM8R5

  • Invasive-pressure external transducer, single-use

Welch Allyn, Inc. - 00732094294699

CONNEX CENTRAL STATION 1.8 SW ONLY
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094294699 ()
107205

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094294682

CONNEX CENTRAL STATION 1.8 - HW & SW
WELCH ALLYN, INC.
901066
Not in Commercial Distribution

  • 00732094294682 ()
107204

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094294675

CSAS 1.8 CONTINUOUS
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094294675 ()
107203

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094294668

CONNEX CSAS 1.8 EPISODIC
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094294668 ()
107202

  • Centralized patient monitor
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