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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CATH 0787533 RF CONDUCTR MC W/O CE
MEDTRONIC, INC.
0787533
In Commercial Distribution

  • 00763000227814 ()

  • Catheter usable length 110 cm
  • Electrode spacing 2.5.2 mm
  • Catheter deflectable tip length 55-75 mm
  • Catheter distal electrode size 4 mm
  • Catheter size 2.3mm (7 Fr)


  • Cardiac radio-frequency ablation system catheter
CATH 31744523 RF ENHANCR II W/O CE
MEDTRONIC, INC.
31744523
In Commercial Distribution

  • 00763000227777 ()

  • Catheter distal electrode size 4 mm
  • Electrode spacing 2.5.2 mm
  • Catheter usable length 110 cm
  • Catheter deflectable tip length 45 mm
  • Catheter size 2.3mm (7 Fr)


  • Cardiac radio-frequency ablation system catheter
CATH 31745523 RF ENHANCR II W/O CE
MEDTRONIC, INC.
31745523
In Commercial Distribution

  • 00763000227760 ()

  • Catheter usable length 110 cm
  • Catheter size 2.3mm (7 Fr)
  • Catheter deflectable tip length 55 mm
  • Electrode spacing 2.5.2 mm
  • Catheter distal electrode size 4 mm


  • Cardiac radio-frequency ablation system catheter
CATH 31745533 RF ENHANCR II W/O CE
MEDTRONIC, INC.
31745533
In Commercial Distribution

  • 00763000227753 ()

  • Catheter distal electrode size 4 mm
  • Catheter usable length 110 cm
  • Electrode spacing 2.5.2 mm
  • Catheter size 2.3mm (7 Fr)
  • Catheter deflectable tip length 55 mm


  • Cardiac radio-frequency ablation system catheter
CATH 39745533 RF ENHANCR II W/O CE
MEDTRONIC, INC.
39745533
In Commercial Distribution

  • 00763000227746 ()

  • Catheter deflectable tip length 55 mm
  • Catheter size 2.3mm (7 Fr)
  • Electrode spacing 2.5.2 mm
  • Catheter distal electrode size 4 mm
  • Catheter usable length 90 cm


  • Cardiac radio-frequency ablation system catheter
CATH 39746534 RF ENHANCR II W/O CE
MEDTRONIC, INC.
39746534
In Commercial Distribution

  • 00763000227739 ()

  • Catheter distal electrode size 4 mm
  • Electrode spacing 2.5.2 mm
  • Catheter usable length 90 cm
  • Catheter size 2.3mm (7 Fr)
  • Catheter deflectable tip length 65 mm


  • Cardiac radio-frequency ablation system catheter
CATH 075402 RF MARINR MCXL W/O CE
MEDTRONIC, INC.
075402
In Commercial Distribution

  • 00763000227722 ()

  • Catheter usable length 110 cm
  • Catheter deflectable tip length 55-75 mm
  • Electrode spacing 2.5.2 mm
  • Catheter size 2.3mm (7 Fr)
  • Catheter distal electrode size 4 mm


  • Cardiac radio-frequency ablation system catheter
CATH 075405 RF MARINR MCXL W/O CE
MEDTRONIC, INC.
075405
In Commercial Distribution

  • 00763000227715 ()

  • Catheter size 2.3mm (7 Fr)
  • Catheter distal electrode size 4 mm
  • Catheter usable length 110 cm
  • Catheter deflectable tip length 55-75 mm
  • Electrode spacing 5.5.5 mm


  • Cardiac radio-frequency ablation system catheter
CATH 075302 RF MARINR MC W/O CE
MEDTRONIC, INC.
075302
In Commercial Distribution

  • 00763000227708 ()

  • Catheter distal electrode size 4 mm
  • Catheter size 2.3mm (7 Fr)
  • Catheter deflectable tip length 40-60 mm
  • Catheter usable length 110 cm
  • Electrode spacing 2.5.2 mm


  • Cardiac radio-frequency ablation system catheter
CATH 075312 RF MARINR MC W/O CE
MEDTRONIC, INC.
075312
In Commercial Distribution

  • 00763000227692 ()

  • Catheter usable length 112 cm
  • Catheter distal electrode size 4 mm
  • Catheter deflectable tip length 45-70 mm
  • Catheter size 2.3mm (7 Fr)
  • Electrode spacing 2.5.2 mm


  • Cardiac radio-frequency ablation system catheter
CATH 076514 RF MARINR SC W/O CE
MEDTRONIC, INC.
076514
In Commercial Distribution

  • 00763000227685 ()

  • Catheter size 1.7mm (5 Fr)
  • Catheter distal electrode size 4 mm
  • Electrode spacing 2.5.2 mm
  • Catheter usable length 110 cm
  • Catheter deflectable tip length 45 mm


  • Cardiac radio-frequency ablation system catheter
CATH 076515 RF MARINR SCXL W/O CE
MEDTRONIC, INC.
076515
In Commercial Distribution

  • 00763000227678 ()

  • Catheter deflectable tip length 55 mm
  • Catheter usable length 110 cm
  • Catheter size 1.7mm (5 Fr)
  • Catheter distal electrode size 4 mm
  • Electrode spacing 2.5.2 mm


  • Cardiac radio-frequency ablation system catheter
CATH 076583 RF MARINR 5F W/O CE
MEDTRONIC, INC.
076583
In Commercial Distribution

  • 00763000227661 ()

  • Catheter deflectable tip length 35 mm
  • Catheter distal electrode size 4 mm
  • Catheter usable length 80 cm
  • Catheter size 1.7mm (5 Fr)
  • Electrode spacing 2.5.2 mm


  • Cardiac radio-frequency ablation system catheter
CATH 076584 RF MARINR 5F SC W/O CE
MEDTRONIC, INC.
076584
In Commercial Distribution

  • 00763000227654 ()

  • Catheter usable length 80 cm
  • Catheter deflectable tip length 45 mm
  • Catheter distal electrode size 4 mm
  • Catheter size 1.7mm (5 Fr)
  • Electrode spacing 2.5.2 mm


  • Cardiac radio-frequency ablation system catheter
CATH 076585 RF MARINR 5F SCXL W/O CE
MEDTRONIC, INC.
076585
In Commercial Distribution

  • 00763000227647 ()

  • Catheter distal electrode size 4 mm
  • Catheter deflectable tip length 55 mm
  • Catheter size 1.7mm (5 Fr)
  • Electrode spacing 2.5.2 mm
  • Catheter usable length 80 cm


  • Cardiac radio-frequency ablation system catheter
CATH 076586 RFMARINR 5F SCXXL W/O CE
MEDTRONIC, INC.
076586
In Commercial Distribution

  • 00763000227630 ()

  • Electrode spacing 2.5.2 mm
  • Catheter deflectable tip length 65 mm
  • Catheter usable length 80 cm
  • Catheter distal electrode size 4 mm
  • Catheter size 1.7mm (5 Fr)


  • Cardiac radio-frequency ablation system catheter
CATH 075802 RF MARINR W/O CE
MEDTRONIC, INC.
075802
In Commercial Distribution

  • 00763000227623 ()

  • Catheter distal electrode size 4 mm
  • Catheter deflectable tip length 40-60 mm
  • Catheter size 2.3mm (7 Fr)
  • Electrode spacing 2.2.250 mm
  • Catheter usable length 110 cm


  • Cardiac radio-frequency ablation system catheter
FOOT SWITCH NITRONFS GLOBAL
MEDTRONIC, INC.
NITRONFS
In Commercial Distribution

  • 00763000911089 ()


  • Foot-switch, electrical
CABLE 203CXC COAX UMBIL BOX 12 TIJ MDR
MEDTRONIC, INC.
203CXC
In Commercial Distribution

  • 20763000412573 ()
  • 00763000412579 ()


  • Liquid nitrous oxide coaxial tubing
CABLE 203CX COAX UMBILICAL ROHS TIJ MDR
MEDTRONIC, INC.
203CX
In Commercial Distribution

  • 00763000412562 ()


  • Liquid nitrous oxide coaxial tubing
CABLE 203CXC COAXIAL UMBIL BOX 12 ROHS
MEDTRONIC, INC.
203CXC
In Commercial Distribution

  • 20643169352784 ()
  • 00643169352780 ()


  • Liquid nitrous oxide coaxial tubing
CABLE 2035UC ELECT UMBILICAL BOX 12 ROHS
MEDTRONIC, INC.
2035UC
Not in Commercial Distribution

  • 20643169352777 ()
  • 00643169352773 ()


  • Electrical-only medical device connection cable, single-use
Uterine Balloon Therapy System
Ethicon Inc.
00825
Not in Commercial Distribution

  • 10705031000865 ()
00825

  • Electrocautery system generator, line-powered
With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For use only with GYNECARE THERMACHOICE TM UBT System Controller
Ethicon Inc.
TC003
Not in Commercial Distribution

  • 20705031050737 ()
  • 10705031050730 ()
TC003

  • Circulating-fluid endometrial-ablation catheter
Uterine Balloon Therapy System with Fluid Circulation
Ethicon Inc.
TC013
Not in Commercial Distribution

  • H206TC0131 ()
  • 20705031050744 ()
TC013

  • Circulating-fluid endometrial-ablation catheter
Thermal Balloon Ablation Umbilical Cable. For use only with GYNECARE THERMACHOICE TM UBT System Controller.
Ethicon Inc.
01105
Not in Commercial Distribution

  • H206011051 ()
  • 20705031000886 ()
01105

  • Electrical-only medical device connection cable, reusable
PRDS-068-02 Paradise® Catheter 8mm
Recor Medical, Inc.
PRDS-068-02
In Commercial Distribution

  • 00810008950043 ()

  • Balloon Diameter: 8 Millimeter
PRDS-068-02

  • Renal denervation ultrasound system catheter
No Description
OLYMPUS Winter & Ibe GmbH
WB920138
Not in Commercial Distribution

  • 14042768201384 ()
  • 04042768201387 ()
WB920138

  • Cardiac ablation system irrigation tubing set
No Description
OLYMPUS Winter & Ibe GmbH
WB920137
Not in Commercial Distribution

  • 14042768201377 ()
  • 04042768201370 ()
WB920137

  • Cardiac ablation system irrigation tubing set
Tubing Set
IRVINE BIOMEDICAL, INC.
85785
In Commercial Distribution

  • 05414734258616 ()
85785

  • Cardiac ablation system irrigation tubing set
No Description
Stockert GmbH
20625
In Commercial Distribution

  • 04260166374353 ()
M004GEN100206251

  • Cardiac ablation system irrigation tubing set
Only commercialized as part of the 10 PK
Stockert GmbH
20626
In Commercial Distribution

  • 04260166374346 ()
M004GEN100206260

  • Cardiac ablation system irrigation tubing set
IRRIGATION KIT - HST
DE SOUTTER MEDICAL LIMITED
T10-102
Not in Commercial Distribution

  • 05051471099050 ()
  • 15051471099057 ()
T10-102

  • Cardiac ablation system irrigation tubing set
Open-Irrigation Tubing Set
BOSTON SCIENTIFIC CORPORATION
M0041170
In Commercial Distribution

  • 08714729862208 ()
M0041170

  • Cardiac ablation system irrigation tubing set
PMP BAYLIS COOLED RF TUBE KIT
Avanos Medical, Inc.
09693
In Commercial Distribution

  • 10680651096934 ()
TDA-TBK-1

  • Cardiac ablation system irrigation tubing set
No Description
Biosense Webster Inc
CFT001
In Commercial Distribution

  • 10846835000016 ()
CFT001

  • Cardiac ablation system irrigation tubing set
COOLIEF* Cooled Radiofrequency Sterile Tube Kit
Avanos Medical, Inc.
09693
In Commercial Distribution

  • 00193493096930 ()
TDA-TBK-1

  • Cardiac ablation system irrigation tubing set
CRA-TBK-2 AVNS,TUBING KIT, TWO PROBES,1
Avanos Medical, Inc.
CRA-TBK-2
In Commercial Distribution

  • 10193493000200 ()
  • 00193493000203 ()
CRA-TBK-2

  • Cardiac ablation system irrigation tubing set
CRA-TBK-1 AVNS,TUBING KIT, ONE PROBE,1
Avanos Medical, Inc.
CRA-TBK-1
In Commercial Distribution

  • 10193493000194 ()
  • 00193493000197 ()
CRA-TBK-1

  • Cardiac ablation system irrigation tubing set
Shipping box carton containing 4 boxes of 10 individual devices; Not commercialized
Stockert GmbH
20624
In Commercial Distribution

  • 04260166374360 ()
M004GEN100206241

  • Cardiac ablation system irrigation tubing set
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