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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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SMARTFREEZE™ - 08714729997481

Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS400Z0
In Commercial Distribution

  • 08714729997481 ()
M004CRBS400Z0

  • 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

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™ - 08714729992752

Evaluation Kit
BOSTON SCIENTIFIC CORPORATION
M004CRBS470D0
In Commercial Distribution

  • 08714729992752 ()
M004CRBS470D0

  • Cardiac cryosurgical system

SMARTFREEZE™ - 08714729992745

Cryo-Console Foot Switch
BOSTON SCIENTIFIC CORPORATION
M004CRBS4200
In Commercial Distribution

  • 08714729992745 ()
M004CRBS4200

  • Foot-switch, electrical

SMARTFREEZE™ - 08714729992721

Cryo-Console
BOSTON SCIENTIFIC CORPORATION
M004CRBS400R0
In Commercial Distribution

  • 08714729992721 ()
M004CRBS400R0

  • 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
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