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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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Inflatable Penile Prosthesis
BOSTON SCIENTIFIC CORPORATION
72401452
In Commercial Distribution

  • 00878953000961 ()

  • Outer Diameter: 12.5 Millimeter
  • Length: 18 Centimeter
72401452

  • Inflatable penile prosthesis
Inflatable Penile Prosthesis
BOSTON SCIENTIFIC CORPORATION
72401450
In Commercial Distribution

  • 00878953000947 ()

  • Outer Diameter: 12.5 Millimeter
  • Length: 14 Centimeter
72401450

  • Inflatable penile prosthesis
No Description
Biomet Orthopedics, LLC
103533
In Commercial Distribution

  • 00880304008700 ()

  • 6.5 mm x 30 mm
103533

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Biomet Orthopedics, LLC
103532
In Commercial Distribution

  • 00880304008694 ()

  • 6.5 mm x 25 mm
103532

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Biomet Orthopedics, LLC
113145
In Commercial Distribution

  • 00880304007802 ()

  • +4MM HEIGHT
113145

  • Bipolar partial shoulder prosthesis
The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months.
SPATZ FGIA (ISRAEL) LTD
A-SP3US-03K
In Commercial Distribution

  • 00860005178803 ()


  • Appetite-suppression gastric balloon
Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo headphones with integrated treatment electrodes. Cervella provides stimulation current intensity ranging from 50uA - 500uA in 50uA increments and user-selectable frequency presets of 0.5Hz, 1.5Hz, and 100Hz.
INNOVATIVE NEUROLOGICAL DEVICES LLC
Cervella CES
In Commercial Distribution

  • 00860001493306 ()
Cervella

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911608400
Not in Commercial Distribution

  • 08714729807742 ()

  • 8 mm Stent Length
  • 4.00 mm Stent Diameter
H7493911608400

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic
Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911638400
Not in Commercial Distribution

  • 08714729807735 ()

  • 38 mm Stent Length
  • 4.00 mm Stent Diameter
H7493911638400

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911632400
Not in Commercial Distribution

  • 08714729807728 ()

  • 4.00 mm Stent Diameter
  • 32 mm Stent Length
H7493911632400

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