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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GENERATOR RDNG3A G3SV5.1 US JP CA
MEDTRONIC, INC.
RDNG3A
In Commercial Distribution

  • 00763000387020 ()


  • Percutaneous radio-frequency ablation system generator
CABLE 2035U ELECTRICAL UMBILICAL BMED
MEDTRONIC, INC.
2035U
In Commercial Distribution

  • 00763000359355 ()


  • Electrical-only medical device connection cable, single-use
CATHETER 217F5 FREEZOR XTRA5 LG 7F
MEDTRONIC, INC.
217F5
In Commercial Distribution

  • 00763000542115 ()

  • Catheter Curve 60mm
  • Electrode spacing 2.5,5.0,2.5mm
  • Catheter Gauge: 7.0 French
  • Catheter Working Length: 108.0 Centimeter
  • Catheter Tip length 6mm


  • Cardiac cryosurgical system catheter
CATHETER 217F3 FREEZOR XTRA3 MED7F
MEDTRONIC, INC.
217F3
In Commercial Distribution

  • 00763000542108 ()

  • Catheter Tip length 6mm
  • Catheter Gauge: 7.0 French
  • Catheter Working Length: 108.0 Centimeter
  • Electrode spacing 2.5,5.0,2.5mm
  • Catheter Curve 55mm


  • Cardiac cryosurgical system catheter
CATHETER 217F1 FREEZOR XTRA SH 7F
MEDTRONIC, INC.
217F1
In Commercial Distribution

  • 00763000542092 ()

  • Catheter Curve 49mm
  • Electrode spacing 2.5,5.0,2.5mm
  • Catheter Gauge: 7.0 French
  • Catheter Working Length: 108.0 Centimeter
  • Catheter Tip length 6mm


  • Cardiac cryosurgical system catheter
CONSOLE NITRON US
MEDTRONIC, INC.
NITRON
In Commercial Distribution

  • 00763000593902 ()


  • Cardiac cryosurgical system
REMOTE NITRONRMT GLOBAL
MEDTRONIC, INC.
NITRONRMT
In Commercial Distribution

  • 00763000593889 ()


  • Cardiac cryosurgical system
SPYRAL CATHETER RDN016 US COMMERCIAL
MEDTRONIC, INC.
RDN016
In Commercial Distribution

  • 00763000354466 ()

  • 1.78 MM Minimum Inner Diameter
  • 1.32 MM Outer Diameter
  • 117 CM Effective Length
  • 19 MM Tip Diameter
  • 6 FR Guide Catheter
  • 0.36 MM Maximum Guidewire Diameter


  • Renal denervation radio-frequency ablation catheter
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 2035UC ELECT UMBILICAL BOX 12 BMED
MEDTRONIC, INC.
2035UC
In Commercial Distribution

  • 00763000359362 ()
  • 20763000359366 ()


  • Electrical-only medical device connection cable, single-use
CABLE 2035UC ELECT UMBILICAL BOX 12 ROHS
MEDTRONIC, INC.
2035UC
In Commercial Distribution

  • 20763000279770 ()
  • 00763000279776 ()


  • Electrical-only medical device connection cable, single-use
CABLE 203CXC COAXIAL UMBIL BOX 12 ROHS
MEDTRONIC, INC.
203CXC
In Commercial Distribution

  • 20763000279756 ()
  • 00763000279752 ()


  • Liquid nitrous oxide coaxial tubing
Her Option Disposable Probe
Coopersurgical, Inc.
CU-1
In Commercial Distribution

  • 20888937000027 ()


  • Hand-held cryosurgical system handpiece tip
FOOT SWITCH NITRONFS GLOBAL
MEDTRONIC, INC.
NITRONFS
In Commercial Distribution

  • 00763000911089 ()


  • Foot-switch, electrical
CABLE 05116 STERILE GLBL
MEDTRONIC, INC.
05116
In Commercial Distribution

  • 00763000719319 ()

  • Length: 366.0 Centimeter


  • Electrical-only medical device connection cable, reusable
CABLE 05106S STERILE GLBL
MEDTRONIC, INC.
05106S
In Commercial Distribution

  • 00763000719265 ()

  • Length: 183.0 Centimeter


  • Electrical-only medical device connection cable, reusable
CATHETER 207F5 FREEZOR5 LONG ORANGE 7F
MEDTRONIC, INC.
207F5
In Commercial Distribution

  • 00763000645342 ()

  • Catheter Gauge: 7.0 French
  • Catheter Working Length: 108.0 Centimeter
  • Catheter Curve 58mm
  • Catheter Tip length 4mm
  • Electrode spacing 2.5,5.0,2.5mm


  • Cardiac cryosurgical system catheter
CATHETER 207F3 FREEZOR3 MED BLUE 7F
MEDTRONIC, INC.
207F3
In Commercial Distribution

  • 00763000645335 ()

  • Catheter Curve 53mm
  • Catheter Working Length: 108.0 Centimeter
  • Catheter Gauge: 7.0 French
  • Electrode spacing 2.5,5.0,2.5mm
  • Catheter Tip length 4mm


  • Cardiac cryosurgical system catheter
CATHETER 207F1 FREEZOR1 SHT RED 7F
MEDTRONIC, INC.
207F1
In Commercial Distribution

  • 00763000645328 ()

  • Catheter Working Length: 108.0 Centimeter
  • Electrode spacing 2.5,5.0,2.5mm
  • Catheter Gauge: 7.0 French
  • Catheter Curve 47mm
  • Catheter Tip length 4mm


  • Cardiac cryosurgical system catheter
PRDS-USG-2X Paradise® Generator with Paradise® Remote
Recor Medical, Inc.
PRDS-USG-2X
In Commercial Distribution

  • 00810008950128 ()
PRDS-USG-2X

  • Renal denervation ultrasound system generator
PRDS-USG-2X Paradise® Generator
Recor Medical, Inc.
PRDS-USG-2X
In Commercial Distribution

  • 00810008950111 ()
PRDS-USG-2X

  • Renal denervation ultrasound system generator
PRDS-RM Paradise® Remote
Recor Medical, Inc.
PRDS-RM
In Commercial Distribution

  • 00810008950098 ()
PRDS-RM

  • Renal denervation ultrasound system generator
PRDS-CT-02 Paradise® Cartridge
Recor Medical, Inc.
PRDS-CT-02
In Commercial Distribution

  • 00810008950074 ()
  • 10810008950071 ()
PRDS-CT-02

  • Renal denervation ultrasound system cooling solution flow chamber
PRDS-063-02 Paradise® Catheter 3.5mm
Recor Medical, Inc.
PRDS-063-02
In Commercial Distribution

  • 00810008950067 ()

  • Balloon Diameter: 3.5 Millimeter
PRDS-063-02

  • Renal denervation ultrasound system catheter
PRDS-CC-02 Paradise® Connection Cable
Recor Medical, Inc.
PRDS-CC-02
In Commercial Distribution

  • 00810008950050 ()
PRDS-CC-02

  • Electrical-only medical device connection cable, single-use
PRDS-067-02 Paradise® Catheter 7mm
Recor Medical, Inc.
PRDS-067-02
In Commercial Distribution

  • 00810008950036 ()

  • Balloon Diameter: 7 Millimeter
PRDS-067-02

  • Renal denervation ultrasound system catheter
PRDS-066-02 Paradise® Catheter 6mm
Recor Medical, Inc.
PRDS-066-02
In Commercial Distribution

  • 00810008950029 ()

  • Balloon Diameter: 6 Millimeter
PRDS-066-02

  • Renal denervation ultrasound system catheter
PRDS-065-02 Paradise® Catheter 5mm
Recor Medical, Inc.
PRDS-065-02
In Commercial Distribution

  • 00810008950012 ()

  • Balloon Diameter: 5 Millimeter
PRDS-065-02

  • Renal denervation ultrasound system catheter
PRDS-064-02 Paradise® Catheter 4.2mm
Recor Medical, Inc.
PRDS-064-02
In Commercial Distribution

  • 00810008950005 ()

  • Balloon Diameter: 4.2 Millimeter
PRDS-064-02

  • Renal denervation ultrasound system catheter
Mara Water Vapor Probe Kit
Coopersurgical, Inc.
DDK-16-050
In Commercial Distribution



  • Water vapour endometrial-ablation applicator
Her Option Console
Coopersurgical, Inc.
CG-1
In Commercial Distribution

  • 00888937000016 ()


  • General cryosurgical system, cryogen gas, electronic
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
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
Ethicon Inc.
00825
Not in Commercial Distribution

  • 10705031000865 ()
00825

  • Electrocautery system generator, line-powered
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
IRRIGATION KIT - HST
DE SOUTTER MEDICAL LIMITED
T10-102
Not in Commercial Distribution

  • 05051471099050 ()
  • 15051471099057 ()
T10-102

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

  • 05414734258616 ()
85785

  • 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
No Description
Biosense Webster Inc
CFT001
In Commercial Distribution

  • 10846835000016 ()
CFT001

  • Cardiac ablation system irrigation tubing set
DW OUTFLOW CASSETTE/TUBE SET
ARTHREX, INC.
AR-6430
In Commercial Distribution

  • 10888867039329 ()
  • 00888867039322 ()
  • M150AR64301 ()
AR-6430

  • Cardiac ablation system irrigation tubing set
TUBING, EXTENSION 6FT. (20-BOX)
ARTHREX, INC.
AR-6220
In Commercial Distribution

  • 00888867039032 ()
  • M150AR62201 ()
  • 10888867039039 ()
AR-6220

  • Cardiac ablation system irrigation tubing set
TBG ADPTR,'Y' DBL SPKD (10-BX)
ARTHREX, INC.
AR-6215
In Commercial Distribution

  • 00888867039025 ()
  • M150AR62151 ()
  • 10888867039022 ()
AR-6215

  • Cardiac ablation system irrigation tubing set
Y-INFLOW TUBING, 7.0MM
ARTHREX, INC.
AR-6200
In Commercial Distribution

  • 10888867039008 ()
  • 00888867039001 ()
AR-6200

  • 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
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