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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
Not 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

PROMUS Element™ Plus - 08714729807292

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911616220
Not in Commercial Distribution

  • 08714729807292 ()

  • 16 mm Stent Length
  • 2.25 mm Stent Diameter
H7493911616220

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

PROMUS Element™ Plus - 08714729807285

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911612220
Not in Commercial Distribution

  • 08714729807285 ()

  • 12 mm Stent Length
  • 2.25 mm Stent Diameter
H7493911612220

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

FARASTAR™ - 00191506052447

Cable Set
BOSTON SCIENTIFIC CORPORATION
M004PF61M499D
In Commercial Distribution

  • 00191506052447 ()
M004PF61M499D

  • Electrocardiographic lead set, reusable
  • Electrical-only medical device connection cable, reusable

NeuroPace® Patient Data Management System (PDMS) - 00855547005007

The NeuroPace® Patient Data Management System (PDMS), part of the NeuroPace® RNS® System, is used to store and provide access to historical RNS® Neurostimulator and patient data. The PDMS can also be used to create and simulate detection settings that can be sent to a user identified NeuroPace® Programmer for use at a later date. PDMS is stand-alone software that is accessible via secure internet connection.
Neuropace, Inc.
Model 4340
In Commercial Distribution

  • 00855547005007 ()


  • Cannulated surgical drill bit, reusable

Exair - 05708932459457

Prolapse Repair System - Anterior
Coloplast A/S
50100
In Commercial Distribution

  • 05708932459457 ()
50100

  • Suturing unit, single-use
  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer

Exair - 05708932459433

Prolapse Repair System - Posterior
Coloplast A/S
50150
In Commercial Distribution

  • 05708932459433 ()
50150

  • Suturing unit, single-use
  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer

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
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