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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3cm Guided Coagulation System Kit
ATRICURE, INC.
CDK-1413
In Commercial Distribution

  • 00818354015249 ()

  • Length: 3 Centimeter


  • Cardiac radio-frequency ablation system generator
1cm Guided Coagulation System Kit
ATRICURE, INC.
CDK-1411
In Commercial Distribution

  • 00818354015201 ()

  • Length: 1 Centimeter


  • Cardiac radio-frequency ablation system generator
Generator
Biosense Webster Inc
D138402
In Commercial Distribution

  • 10846835018080 ()
D138402

  • Cardiac radio-frequency ablation system generator
Irrigation Pump
Biosense Webster Inc
D139702
In Commercial Distribution

  • 10846835017472 ()
D139702

  • Cardiac radio-frequency ablation system generator
No Description
Biosense Webster Inc
CFP002
Not in Commercial Distribution

  • 10846835000085 ()
CFP002

  • Cardiac radio-frequency ablation system generator
GENERATOR CEDTG200 FASTR RF US
MEDTRONIC, INC.
CEDTG200
In Commercial Distribution

  • 00763000708917 ()


  • Cardiac radio-frequency ablation system generator
GENERATOR CEDTG200 FASTR RF US/CAN
MEDTRONIC, INC.
CEDTG200
In Commercial Distribution

  • 00763000687960 ()


  • Cardiac radio-frequency ablation system generator
GENERATOR CEDTG200 FASTR RF LOANER US
MEDTRONIC, INC.
CEDTG200
In Commercial Distribution

  • 00763000745516 ()


  • Cardiac radio-frequency ablation system generator
CLAMP 49351 CARDIOBLATE GEMINI-S FT
MEDTRONIC, INC.
49351
In Commercial Distribution

  • 00763000841607 ()


  • Cardiac radio-frequency ablation system generator
CARDIOBLATE GEMINI-S 49260 EN
MEDTRONIC, INC.
49260
In Commercial Distribution

  • 00763000841591 ()


  • Cardiac radio-frequency ablation system generator
GENERATOR AFR-00004 HEXAGEN RF US
MEDTRONIC, INC.
AFR-00004
In Commercial Distribution

  • 00763000871864 ()


  • Cardiac radio-frequency ablation system generator
GENERATOR CEDTG200 FASTR RF US
MEDTRONIC, INC.
CEDTG200
In Commercial Distribution

  • 00763000482190 ()


  • Cardiac radio-frequency ablation system generator
CARDIOBLATE 60841 LP STANDALONE EN
MEDTRONIC, INC.
60841
In Commercial Distribution

  • 00885074359618 ()


  • Cardiac radio-frequency ablation system generator
CARDIOBLATE 60832 BP2 SYSTEM, EN
MEDTRONIC, INC.
60832
In Commercial Distribution

  • 00885074266077 ()


  • Cardiac radio-frequency ablation system generator
CARDIOBLATE 60831 BP2 DEVICE EN
MEDTRONIC, INC.
60831
In Commercial Distribution

  • 00885074266022 ()


  • Cardiac radio-frequency ablation system generator
ADAPTER 60884 DISP ELEC ADPTR 15 LANG
MEDTRONIC, INC.
60884
Not in Commercial Distribution

  • 00885074243092 ()


  • Cardiac radio-frequency ablation system generator
Surgical Ablation System Open, Standard Jaw with Glidepath Magnetic Guide
ATRICURE, INC.
OSH
In Commercial Distribution

  • 30840143904817 ()
  • 10840143905995 ()
  • 50840143904071 ()
  • 10840143905209 ()
A001144SB

  • Cardiac radio-frequency ablation system generator
Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide
ATRICURE, INC.
OLH
In Commercial Distribution

  • 10840143905834 ()
  • 10840143905193 ()
  • 30840143904800 ()
  • 50840143904064 ()
A001143SB

  • Cardiac radio-frequency ablation system generator
Glidepath Magnetic Guide
ATRICURE, INC.
GPM100
In Commercial Distribution

  • 10840143905520 ()
  • 30840143904824 ()
  • 50840143904088 ()
  • 10840143904134 ()
A001212SB

  • Cardiac radio-frequency ablation system generator
Surgical Ablation System Open, Long Jaw with Glidepath Magnetic Guide
ATRICURE, INC.
OLH
In Commercial Distribution

  • 10840143904110 ()
  • 30840143903353 ()
  • 50840143900066 ()
A001143

  • Cardiac radio-frequency ablation system generator
C2 CryoBalloon Focal Pear Catheter for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1033
In Commercial Distribution

  • 00854924006330 ()
FG-1033

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
C2 CryoBalloon Full 8 Catheter for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1032
In Commercial Distribution

  • 00854924006323 ()
FG-1032

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Controller for Full and Swipe C2 CryoBalloon Ablation System (translating)
C2 THERAPEUTICS, INC.
FG-1006
In Commercial Distribution

  • 00854924006064 ()
FG-1006

  • High-pressure medical gas hose
  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.0.2
In Commercial Distribution

  • 05415067050021 ()
ENSITE-TFM-3.0.2

  • Cardiac mapping system application software
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.1
In Commercial Distribution

  • 05415067049711 ()
ENSITE-TFM-3.1

  • Cardiac mapping system application software
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-02
In Commercial Distribution

  • 05415067046673 ()
ENSITE-TFM-02

  • Cardiac mapping system application software
RF ARTHROSCOPY PROBE SAPHYRE BIPOLAR ABLATION 60 DEGREE W/SUCTION
STERILMED, INC.
SMI7209682
Not in Commercial Distribution

  • 10888551034494 ()
SMI7209682

  • Endoscopic electrosurgical electrode, bipolar, reprocessed
No Description
STARMED CO.,LTD
7-VENI0070N
In Commercial Distribution

  • 18809306767872 ()
  • 08809306767875 ()
  • 28809306767879 ()


  • Peripheral vascular radio-frequency ablation catheter
No Description
STARMED CO.,LTD
3-VENI0030N
In Commercial Distribution

  • 18809306767865 ()
  • 08809306767868 ()
  • 28809306767862 ()


  • Peripheral vascular radio-frequency ablation catheter
No Description
STARMED CO.,LTD
3-VENI003090N
In Commercial Distribution

  • 18809306764871 ()
  • 08809306764874 ()
  • 28809306764878 ()


  • Peripheral vascular radio-frequency ablation catheter
No Description
STARMED CO.,LTD
7-VENI007090N
In Commercial Distribution

  • 18809306764017 ()
  • 08809306764010 ()
  • 28809306764014 ()


  • Peripheral vascular radio-frequency ablation catheter
Ultrasound -guided intrauterine electrosurgical system ultrasound control unit
Gynesonics, Inc.
USCON-2200
In Commercial Distribution

  • 10817929020197 ()
USCON-2200

  • Ultrasound-guided intrauterine radio-frequency ablation system ultrasound control unit
STYLET RFS2-6-12 CLOSUREFAST
MEDTRONIC, INC.
RFS2-6-12
In Commercial Distribution

  • 00763000723293 ()

  • Maximum electrode diameter: 6 Fr
  • Length: 12.0 Centimeter


  • Peripheral vascular radio-frequency ablation catheter
Temperature Sensor - Use only with IceCure Cryogenic device
ICECURE MEDICAL LTD
FAT8000000
Not in Commercial Distribution

  • 07290015487061 ()

  • Shaft Length: 170 Millimeter
  • Needle Gauge: 14 Gauge
FAT8000000

  • Cryosurgical system temperature probe
SpineryTM Connections are cooling tubing to connect the needle handle with the cooling solution.The connection provides send and return of sterile saline water from the bag to connected needle. The single connection cooling tube is for use with one bipolar RF needle with a product code of SP-CS.
AXON SRL
SP-CS
In Commercial Distribution

  • 00860011603696 ()


  • Percutaneous radio-frequency ablation probe cooling tubing set
SpineryTM Connections are cooling tubing to connect the needle handle with the cooling solution.The connection provides send and return of sterile saline water from the bag to connected needle. The double connection cooling tube is for use with two bipolar RF needles with a product code of SP-CD.
AXON SRL
SP-CD
In Commercial Distribution

  • 00860011603627 ()


  • Percutaneous radio-frequency ablation probe cooling tubing set
CONTROLLER TO PUMP OR REMOTE CONTROL
BOSTON SCIENTIFIC CORPORATION
M0046640
In Commercial Distribution

  • 08714729861904 ()

  • 2286 cm Length
M0046640

  • Cardiac ablation system cable, reusable
CONTROLLER TO PUMP OR REMOTE CONTROL
BOSTON SCIENTIFIC CORPORATION
M0046630
In Commercial Distribution

  • 08714729861898 ()

  • 1524 cm Length
M0046630

  • Cardiac ablation system cable, reusable
CONTROLLER TO PUMP OR REMOTE CONTROL
BOSTON SCIENTIFIC CORPORATION
M0046610
In Commercial Distribution

  • 08714729861874 ()

  • 610 cm Length
M0046610

  • Cardiac ablation system cable, reusable
CONTROLLER TO PUMP OR REMOTE CONTROL
BOSTON SCIENTIFIC CORPORATION
M0046620
In Commercial Distribution

  • 08714729861881 ()

  • 762 cm Length
M0046620

  • Cardiac ablation system cable, reusable
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