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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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POLARx™ FIT - 08714729992622

Cryoablation Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M004CRBS2060
In Commercial Distribution

  • 08714729992622 ()

  • 11.8F Catheter Shaft Size
M004CRBS2060

  • Cardiac cryosurgical system catheter

SMARTFREEZE™ - 08714729997481

Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS400Z0
In Commercial Distribution

  • 08714729997481 ()
M004CRBS400Z0

  • Cardiac cryosurgical system

SMARTFREEZE™ - 08714729992752

Evaluation Kit
BOSTON SCIENTIFIC CORPORATION
M004CRBS470D0
In Commercial Distribution

  • 08714729992752 ()
M004CRBS470D0

  • Cardiac cryosurgical system

SMARTFREEZE™ - 08714729992738

Inter-Connection Box
BOSTON SCIENTIFIC CORPORATION
M004CRBS4110
In Commercial Distribution

  • 08714729992738 ()
M004CRBS4110

  • Electrosurgical cable adaptor

SMARTFREEZE™ - 08714729992714

Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS400H0
In Commercial Distribution

  • 08714729992714 ()
M004CRBS400H0

  • Cardiac cryosurgical system

SMARTFREEZE™ - 08714729992691

Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS4000
In Commercial Distribution

  • 08714729992691 ()
M004CRBS4000

  • Cardiac cryosurgical system

POLARx™ - 08714729992677

Cryoablation Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M004CRBS2150
In Commercial Distribution

  • 08714729992677 ()

  • Outer Diameter: 4 Millimeter
M004CRBS2150

  • Cardiac cryosurgical system catheter

POLARx™ - 08714729992615

Cryoablation Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M004CRBS2050
In Commercial Distribution

  • 08714729992615 ()

  • Outer Diameter: 4 Millimeter
M004CRBS2050

  • Cardiac cryosurgical system catheter

Cable, IntellaTip MiFi™ OI - 08714729877424

Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M0046270
In Commercial Distribution

  • 08714729877424 ()

  • 10 ft Length
  • 305 cm Length
M0046270

  • Electrical-only medical device connection cable, reusable

MetriQ™ Pump - 08714729862260

Irrigation Pump
BOSTON SCIENTIFIC CORPORATION
M00441000
In Commercial Distribution

  • 08714729862260 ()
M00441000

  • Basic roller pump

MetriQ™ Foot Switch - 08714729862147

Irrigation Pump Foot Swicth
BOSTON SCIENTIFIC CORPORATION
M0044105F0
In Commercial Distribution

  • 08714729862147 ()
M0044105F0

  • Foot-switch, electrical

MetriQ™ Pump - 08714729862123

Irrigation Pump
BOSTON SCIENTIFIC CORPORATION
M0044100R0
In Commercial Distribution

  • 08714729862123 ()
M0044100R0

  • Basic roller pump

MetriQ™ Pump - 08714729862116

Irrigation Pump
BOSTON SCIENTIFIC CORPORATION
M0044100H0
In Commercial Distribution

  • 08714729862116 ()
M0044100H0

  • Basic roller pump

MetriQ™ Pump - 08714729862109

Irrigation Pump
BOSTON SCIENTIFIC CORPORATION
M0044100D0
In Commercial Distribution

  • 08714729862109 ()
M0044100D0

  • Basic roller pump

Cable, Maestro 4000™ - 08714729861867

Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M0046710
In Commercial Distribution

  • 08714729861867 ()

  • 10 ft Length
  • 305 cm Length


  • Electrical-only medical device connection cable, reusable

IntellaTip MiFi™ Filter Module - 08714729854395

RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M0041212H0
In Commercial Distribution

  • 08714729854395 ()


  • Electronic signal frequency filter

IntellaTip MiFi™ Reference Cable - 08714729847946

Non-Sterile Electrophysiology Cable
BOSTON SCIENTIFIC CORPORATION
M00436360
In Commercial Distribution

  • 08714729847946 ()
M00436360

  • Electrical-only medical device connection cable, reusable

Cable, IntellaTip MiFi™ XP - 08714729847953

Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M0046200
In Commercial Distribution

  • 08714729847953 ()
M0046200

  • Electrical-only medical device connection cable, reusable

IntellaTip MiFi™ Filter Module - 08714729847939

RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M00412120
In Commercial Distribution

  • 08714729847939 ()


  • Electronic signal frequency filter

N/A - 10846835003680

No Description
Biosense Webster Inc
C6MR10EPTST
In Commercial Distribution

  • 10846835003680 ()
C6MR10EPTST

  • Electrical-only medical device connection cable, reusable
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