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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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No Description
Edwards Lifesciences LLC
2625
In Commercial Distribution

  • 00690103021530 ()

  • MOUNTING DIAMETER (ANNULUS), 23 MILLIMETER
262523MM

  • Aortic open-surgery heart valve bioprosthesis
No Description
Edwards Lifesciences LLC
2625
In Commercial Distribution

  • 00690103021523 ()

  • MOUNTING DIAMETER (ANNULUS), 21 MILLIMETER
262521MM

  • Aortic open-surgery heart valve bioprosthesis
No Description
Edwards Lifesciences LLC
2625
In Commercial Distribution

  • 00690103021516 ()

  • MOUNTING DIAMETER (ANNULUS), 19 MILLIMETER
262519MM

  • Aortic open-surgery heart valve bioprosthesis
SoftVue™ Automated Whole Breast Ultrasound System With Sequr™ Breast Interface Assembly
Delphinus Medical Technologies, Inc
Atlantic
In Commercial Distribution

  • 00860000221306 ()
900-00035

  • Breast ultrasound imaging system
An implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. The medical device is a plastic arc, of about 150 degrees, that is inserted into the cornea via an intrastromal channel. It is typically available in sizes from 0.250 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI
In Commercial Distribution

  • 00866304000104 ()


  • Intracorneal ring segment
  • Intracorneal ring
Balloon Fill Media
CARDIOFOCUS, INC.
18-1342
In Commercial Distribution

  • 00868976000130 ()

  • Total Volume: 95 Milliliter
18-1342

  • Vascular balloon catheter fill-media
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
DS-1
In Commercial Distribution

  • 00862478000414 ()


  • Supersaturated oxygen therapy system
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion
THEROX, INC.
DS-1 (Refurbished)
In Commercial Distribution

  • 00862478000407 ()


  • Supersaturated oxygen therapy system
The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure.
Pramand LLC
CS-2055
In Commercial Distribution

  • 00860010683712 ()
  • 00860010683705 ()

  • Total Volume: 5 Milliliter
CS-2055

  • Dura mater sealant
STENT SC8150LV COMPLETE SE LONG US V G
MEDTRONIC, INC.
SC8150LV
Not in Commercial Distribution

  • 00643169150829 ()

  • Stent Inner Diameter 8 MM
  • Length: 150.0 Millimeter


  • Peripheral artery stent, bare-metal
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