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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Field Generator Spacer
Covidien LP
CAFGSP1
In Commercial Distribution

  • 10884521703261 ()


  • Foam-filled bed mattress overlay
Field Generator Cart
Covidien LP
CAFGCART1
In Commercial Distribution

  • 10884521703230 ()


  • Electromechanical device/system transport trolley
Field Generator
Covidien LP
CAFG1
In Commercial Distribution

  • 10884521703223 ()


  • Non-evacuated blood collection tube IVD, clot activator/separator
Cryo-Console Foot Switch
BOSTON SCIENTIFIC CORPORATION
M004CRBS4200
In Commercial Distribution

  • 08714729992745 ()
M004CRBS4200

  • Foot-switch, electrical
Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS400R0
In Commercial Distribution

  • 08714729992721 ()
M004CRBS400R0

  • Cardiac cryosurgical system
Cryoablation Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M004CRBS2060
In Commercial Distribution

  • 08714729992622 ()

  • 11.8F Catheter Shaft Size
M004CRBS2060

  • Cardiac cryosurgical system catheter
Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS400Z0
In Commercial Distribution

  • 08714729997481 ()
M004CRBS400Z0

  • Cardiac cryosurgical system
Evaluation Kit
BOSTON SCIENTIFIC CORPORATION
M004CRBS470D0
In Commercial Distribution

  • 08714729992752 ()
M004CRBS470D0

  • Cardiac cryosurgical system
Inter-Connection Box
BOSTON SCIENTIFIC CORPORATION
M004CRBS4110
In Commercial Distribution

  • 08714729992738 ()
M004CRBS4110

  • Electrosurgical cable adaptor
Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS400H0
In Commercial Distribution

  • 08714729992714 ()
M004CRBS400H0

  • Cardiac cryosurgical system
Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS4000
In Commercial Distribution

  • 08714729992691 ()
M004CRBS4000

  • Cardiac cryosurgical system
Cryoablation Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M004CRBS2150
In Commercial Distribution

  • 08714729992677 ()

  • Outer Diameter: 4 Millimeter
M004CRBS2150

  • Cardiac cryosurgical system catheter
Cryoablation Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M004CRBS2050
In Commercial Distribution

  • 08714729992615 ()

  • Outer Diameter: 4 Millimeter
M004CRBS2050

  • Cardiac cryosurgical system catheter
Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M0046270
In Commercial Distribution

  • 08714729877424 ()

  • 10 ft Length
  • 305 cm Length
M0046270

  • Electrical-only medical device connection cable, reusable
Irrigation Pump
BOSTON SCIENTIFIC CORPORATION
M00441000
In Commercial Distribution

  • 08714729862260 ()
M00441000

  • Basic roller pump
Irrigation Pump Foot Swicth
BOSTON SCIENTIFIC CORPORATION
M0044105F0
In Commercial Distribution

  • 08714729862147 ()
M0044105F0

  • Foot-switch, electrical
Irrigation Pump
BOSTON SCIENTIFIC CORPORATION
M0044100R0
In Commercial Distribution

  • 08714729862123 ()
M0044100R0

  • Basic roller pump
Irrigation Pump
BOSTON SCIENTIFIC CORPORATION
M0044100H0
In Commercial Distribution

  • 08714729862116 ()
M0044100H0

  • Basic roller pump
Irrigation Pump
BOSTON SCIENTIFIC CORPORATION
M0044100D0
In Commercial Distribution

  • 08714729862109 ()
M0044100D0

  • Basic roller pump
Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M0046710
In Commercial Distribution

  • 08714729861867 ()

  • 10 ft Length
  • 305 cm Length


  • Electrical-only medical device connection cable, reusable
RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M0041212H0
In Commercial Distribution

  • 08714729854395 ()


  • Electronic signal frequency filter
Non-Sterile Electrophysiology Cable
BOSTON SCIENTIFIC CORPORATION
M00436360
In Commercial Distribution

  • 08714729847946 ()
M00436360

  • Electrical-only medical device connection cable, reusable
Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M0046200
In Commercial Distribution

  • 08714729847953 ()
M0046200

  • Electrical-only medical device connection cable, reusable
RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M00412120
In Commercial Distribution

  • 08714729847939 ()


  • Electronic signal frequency filter
No Description
Biosense Webster Inc
C6MR10EPTST
In Commercial Distribution

  • 10846835003680 ()
C6MR10EPTST

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
C6MR10EPTRS
In Commercial Distribution

  • 10846835003666 ()
C6MR10EPTRS

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
C10MRMSTKDTCS
In Commercial Distribution

  • 10846835003406 ()
C10MRMSTKDTCS

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
C5MHDTCMHS
In Commercial Distribution

  • 10846835000191 ()
C5MHDTCMHS

  • Electrical-only medical device connection cable, reusable
No Description
Biosense Webster Inc
C10MR10MSTKS
In Commercial Distribution

  • 10846835000184 ()
C10MR10MSTKS

  • Electrical-only medical device connection cable, reusable
CONSOLE 106A3 GEN V CRYOCONSOLE US CAN
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00613994775955 ()


  • Cardiac cryosurgical system
CONSOLE 106A3 GEN V CRYOCONSOLE
Medtronic CryoCath LP
106A3
In Commercial Distribution

  • 00643169449596 ()


  • Cardiac cryosurgical system
KIT 20MRK ARCTIC FRONT MANUALRETRACTION
MEDTRONIC, INC.
20MRK
Not in Commercial Distribution

  • 00643169023239 ()


  • Catheter/overtube balloon inflator, single-use
CATHETER 2AF282 ARCTIC FRONT 28MM BLUE
MEDTRONIC, INC.
2AF282
Not in Commercial Distribution

  • 00643169007581 ()

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


  • Cardiac cryosurgical system catheter
CATHETER 2AF232 ARCTIC FRONT 23MM RED
MEDTRONIC, INC.
2AF232
Not in Commercial Distribution

  • 00643169007574 ()

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


  • Cardiac cryosurgical system catheter
CONSOLE 106A3 GEN V CRYOCONSOLE US
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00643169203150 ()


  • Cardiac cryosurgical system
CONSOLE 106A3 GEN V CRYO US LOANER
Medtronic CryoCath LP
106A3
Not in Commercial Distribution

  • 00643169195844 ()


  • Cardiac cryosurgical system
CATHETER 2AF284 ARCTIC FRONT ADV US 28MM
MEDTRONIC, INC.
2AF284
Not in Commercial Distribution

  • 00643169105539 ()

  • Catheter shaft size 10.5 Fr
  • Length: 95.0 Centimeter
  • Balloon inflation size 28 mm


  • Cardiac cryosurgical system catheter
CATHETER 2AF234 ARCTIC FRONT ADV US 23MM
MEDTRONIC, INC.
2AF234
Not in Commercial Distribution

  • 00643169105515 ()

  • Balloon inflation size 23 mm
  • Length: 95.0 Centimeter
  • Catheter shaft size 10.5 Fr


  • Cardiac cryosurgical system catheter
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
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
CONSOLE 106A3 GENV CRYOCONSOLE US CPU
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00643169279063 ()


  • Cardiac cryosurgical system
CONSOLE 106A3 GENV CRYOCONSOLE US
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00643169273405 ()


  • Cardiac cryosurgical system
No Description
Stockert GmbH
20402
In Commercial Distribution

  • 04260166374087 ()
M004GEN100204020

  • Bedside infusion pump, single-channel
No Description
Stockert GmbH
20087
In Commercial Distribution

  • 04260166373264 ()
M004GEN100200870

  • Electrical-only medical device connection cable, reusable
CONSOLE 106A3 GEN V CRYOCONSOLE US
MEDTRONIC, INC.
106A3
Not in Commercial Distribution

  • 00613994686077 ()


  • Cardiac cryosurgical system
KIT 20MRK ARCTIC FRNT MANETRACT GLB ROHS
MEDTRONIC, INC.
20MRK
In Commercial Distribution

  • 00643169495814 ()


  • Catheter/overtube balloon inflator, single-use
Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer
Analog Output Cable
ST. JUDE MEDICAL, INC.
PN-001427
In Commercial Distribution

  • 07640157990217 ()
PN-001427

  • Electrical-only medical device connection cable, reusable
Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer
Mount
ST. JUDE MEDICAL, INC.
PN-004511
In Commercial Distribution

  • 07640157990187 ()
PN-004511

  • Medical device service rail clamp
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