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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 - 08714729807308

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911620220
In Commercial Distribution

  • 08714729807308 ()

  • 2.25 mm Stent Diameter
  • 20 mm Stent Length
H7493911620220

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

Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA - 07290015461887

A Kit for 10 Neuro treatment (Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA). Kit content: Part Description SET001045 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) X 2 units
INSIGHTEC LTD
SET001102 Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461887 ()
SET001102

  • Therapeutic oncological/gynaecological ultrasound system

VeriFLEX™ - 08714729471400

Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493893532450
Not in Commercial Distribution

  • 08714729471400 ()

  • 32 mm Stent Length
  • 4.5 mm Stent Diameter
H7493893532450

  • Bare-metal coronary artery stent
  • Coronary angioplasty balloon catheter, basic

VeriFLEX™ - 08714729471394

Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493893528500
Not in Commercial Distribution

  • 08714729471394 ()

  • 5.0 mm Stent Diameter
  • 28 mm Stent Length
H7493893528500

  • Bare-metal coronary artery stent
  • Coronary angioplasty balloon catheter, basic

VeriFLEX™ - 08714729471387

Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493893528450
Not in Commercial Distribution

  • 08714729471387 ()

  • 4.5 mm Stent Diameter
  • 28 mm Stent Length
H7493893528450

  • Coronary angioplasty balloon catheter, basic
  • Bare-metal coronary artery stent

VeriFLEX™ - 08714729471417

Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493893532500
Not in Commercial Distribution

  • 08714729471417 ()

  • 32 mm Stent Length
  • 5.0 mm Stent Diameter
H7493893532500

  • Coronary angioplasty balloon catheter, basic
  • Bare-metal coronary artery stent

REBEL™ - 08714729844570

Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493927532450
In Commercial Distribution

  • 08714729844570 ()

  • 32 mm Stent Length
  • 4.50 mm Stent Diameter
H7493927532450

  • Coronary angioplasty balloon catheter, basic
  • Bare-metal coronary artery stent

REBEL™ - 08714729844563

Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493927532400
In Commercial Distribution

  • 08714729844563 ()

  • 4.00 mm Stent Diameter
  • 32 mm Stent Length
H7493927532400

  • Coronary angioplasty balloon catheter, basic
  • Bare-metal coronary artery stent

REBEL™ - 08714729844556

Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493927532350
In Commercial Distribution

  • 08714729844556 ()

  • 3.50 mm Stent Diameter
  • 32 mm Stent Length
H7493927532350

  • Bare-metal coronary artery stent
  • Coronary angioplasty balloon catheter, basic

REBEL™ - 08714729844549

Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493927532300
In Commercial Distribution

  • 08714729844549 ()

  • 32 mm Stent Length
  • 3.00 mm Stent Diameter
H7493927532300

  • Bare-metal coronary artery stent
  • Coronary angioplasty balloon catheter, basic
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