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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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Impella - 04260113630303

Guide Wire 0.018" PTFE coated
Abiomed, Inc.
0052-3005
In Commercial Distribution

  • 04260113630303 ()
0052-3005

  • Intracardiac circulatory assist axial-pump catheter

Impella - 04260113630259

Sterile Connector Cable Pump / IMC
Abiomed, Inc.
0042-0002
In Commercial Distribution

  • 04260113630259 ()
0042-0002

  • Electrical-only medical device connection cable, single-use

FARASTAR™ - 00191506041663

Catheter Connection Cable
BOSTON SCIENTIFIC CORPORATION
M004PF41M444
In Commercial Distribution

  • 00191506041663 ()
M004PF41M444

  • Electrical-only medical device connection cable, single-use

FARASTAR™ - 00191506041656

Catheter Connection Cable
BOSTON SCIENTIFIC CORPORATION
M004PF41M434
In Commercial Distribution

  • 00191506041656 ()
M004PF41M434

  • Electrical-only medical device connection cable, single-use

SMARTFREEZE™ - 00191506039677

Catheter Extension Cable
BOSTON SCIENTIFIC CORPORATION
M004CRBS5110
In Commercial Distribution

  • 00191506039677 ()
M004CRBS5110

  • Electrical-only medical device connection cable, single-use

AngioSculpt® PTCA Scoring Balloon Catheter - M3702200353011

No Description
Angioscore Inc.
2200-2520
In Commercial Distribution

  • M3702200353011 ()


  • Coronary angioplasty balloon catheter, basic

AngioSculpt® PTCA Scoring Balloon Catheter - M3702200352012

No Description
Angioscore Inc.
2200-3520
In Commercial Distribution

  • M3702200352012 ()


  • Coronary angioplasty balloon catheter, basic

AngioSculpt® PTCA Scoring Balloon Catheter - M3702200351516

No Description
Angioscore Inc.
2200-3515
In Commercial Distribution

  • M3702200351516 ()


  • Coronary angioplasty balloon catheter, basic

AngioSculpt® PTCA Scoring Balloon Catheter - M3702200351011

No Description
Angioscore Inc.
2200-3510
In Commercial Distribution

  • M3702200351011 ()


  • Coronary angioplasty balloon catheter, basic

AngioSculpt® PTCA Scoring Balloon Catheter - M3702200350616

No Description
Angioscore Inc.
2200-3506
In Commercial Distribution

  • M3702200350616 ()


  • Coronary angioplasty balloon catheter, basic
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