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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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PROMUS Element™ Plus - 08714729807353

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911612250
In Commercial Distribution

  • 08714729807353 ()

  • 12 mm Stent Length
  • 2.50 mm Stent Diameter
H7493911612250

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807346

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911608220
In Commercial Distribution

  • 08714729807346 ()

  • 2.25 mm Stent Diameter
  • 8 mm Stent Length
H7493911608220

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

PROMUS Element™ Plus - 08714729807339

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911632220
In Commercial Distribution

  • 08714729807339 ()

  • 32 mm Stent Length
  • 2.25 mm Stent Diameter
H7493911632220

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic

Curaplex - 00815277020664

BTM Light Weight Monitoring Defib Module
BOUND TREE MEDICAL, LLC
2525-61323
In Commercial Distribution

  • 00815277020664 ()


  • Blood pressure cuff, reusable
  • Transcutaneous blood gas monitor sensor
  • Intracardiac oximeter
  • General-purpose patient temperature probe, single-use

X-STOP® Interspinous Spacer - 00643169117600

TRAY 3-3001 X STOP INSTRUMENT TRAY US
MEDTRONIC SOFAMOR DANEK, INC.
3-3001
In Commercial Distribution

  • 00643169117600 ()


  • Instrument tray, reusable

X-STOP® Interspinous Spacer - 00643169117587

TRAY 4-2000 US X STOP INSTRUMENT SET
MEDTRONIC SOFAMOR DANEK, INC.
4-2000
In Commercial Distribution

  • 00643169117587 ()


  • Instrument tray, reusable

X-STOP® Interspinous Spacer - 00643169117556

TRAY 4-3500 US X STOP PK INSTRUMENT SET
MEDTRONIC SOFAMOR DANEK, INC.
4-3500
In Commercial Distribution

  • 00643169117556 ()


  • Instrument tray, reusable

X-STOP® Interspinous Spacer - 00643169117549

INSTRUMENTS 4-5500 X STOP PEEK US
MEDTRONIC SOFAMOR DANEK, INC.
4-5500
Not in Commercial Distribution

  • 00643169117549 ()


  • Instrument tray, reusable

FlexNav™ - 05415067031389

Delivery System
ST. JUDE MEDICAL, INC.
FNAV-DS-LG
In Commercial Distribution

  • 05415067031389 ()

  • Catheter Gauge: 19.0000 French
  • Length: 107.0000 Centimeter
FNAV-DS-LG

  • Transcatheter heart valve bioprosthesis implantation catheter

FlexNav™ - 05415067031372

Delivery System
ST. JUDE MEDICAL, INC.
FNAV-DS-SM
In Commercial Distribution

  • 05415067031372 ()

  • Catheter Gauge: 18.0000 French
  • Length: 107.0000 Centimeter
FNAV-DS-SM

  • Transcatheter heart valve bioprosthesis implantation catheter
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