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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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HexaPulse™ PF Generator - 00763000871925

GENERATOR AFR-00008 HEXAPULSE PF US
MEDTRONIC, INC.
AFR-00008
In Commercial Distribution

  • 00763000871925 ()


  • Cardiac irreversible electroporation system generator

HexaFlow™ Irrigation Pump - 00763000871895

IRRIGATION PUMP AFR-00005 HEXAFLOW US
MEDTRONIC, INC.
AFR-00005
In Commercial Distribution

  • 00763000871895 ()


  • Basic roller pump

NA - 00763000871802

CABLE AFR-00006 EXTENSION 1PK US
MEDTRONIC, INC.
AFR-00006
In Commercial Distribution

  • 00763000871802 ()


  • Electrical-only medical device connection cable, single-use

N/A - 07613327515794

Ablation Cable from SMARTABLATE System to CELSIUS Catheter or CARTO XP System PIU (DS)
STRYKER SUSTAINABILITY SOLUTIONS, INC.
N/A
In Commercial Distribution

  • 07613327515794 ()

  • Length: 10.0 Feet
D130303

  • Electrical-only medical device connection cable, reprocessed

OsteoCool™ 2.0 RF Ablation System - 00763000764050

CART OCA01-100 OC 2.0 100W STAND
MEDTRONIC SOFAMOR DANEK, INC.
OCA01-100
In Commercial Distribution

  • 00763000764050 ()


  • Medical device integration rack

Arctic Front® - 00643169073265

CATHETER 2AF282 ARCTIC FRONT 28MM BLUE
MEDTRONIC, INC.
2AF282
Not in Commercial Distribution

  • 00643169073265 ()

  • Balloon inflation size 28 mm
  • Balloon tip size 9 Fr
  • Catheter shaft size 10.5 Fr
  • Length: 100.0 Centimeter


  • Cardiac cryosurgical system catheter

Arctic Front® - 00643169073258

CATHETER 2AF232 ARCTIC FRONT 23MM RED
MEDTRONIC, INC.
2AF232
Not in Commercial Distribution

  • 00643169073258 ()

  • Length: 100.0 Centimeter
  • Catheter shaft size 10.5 Fr
  • Balloon tip size 9 Fr
  • Balloon inflation size 23 mm


  • Cardiac cryosurgical system catheter

NA - 00643169023239

KIT 20MRK ARCTIC FRONT MANUALRETRACTION
MEDTRONIC, INC.
20MRK
Not in Commercial Distribution

  • 00643169023239 ()


  • Catheter/overtube balloon inflator, single-use

NA - 00643169279063

CONSOLE 106A3 GENV CRYOCONSOLE US CPU
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00643169279063 ()


  • Cardiac cryosurgical system

NA - 00643169273405

CONSOLE 106A3 GENV CRYOCONSOLE US
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00643169273405 ()


  • Cardiac cryosurgical system
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