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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Adept (4% icodextrin solution) is a single use, sterile, clear, colorless to pale yellow fluid for intraperitoneal administration, containing icodextrin at a concentration of 4% w/v in an electrolyte solution, presented in a flexible polyvinylchloride bag. Adept is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.
BAXTER INTERNATIONAL INC.
0600041
In Commercial Distribution

  • 00085412086217 ()
  • 50085412086212 ()

  • Total Volume: 1500 Milliliter
0600041

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
OBALON Touch™ Dispenser Kit - contains one OBALON Touch™ Dispenser, one OBALON® Balloon Evacuator, 1 Screwdriver, and Batteries
Reshape Lifesciences Inc.
9300-0001
Not in Commercial Distribution

  • 00859810006203 ()


  • Appetite-suppression gastric balloon inflation regulator
  • Appetite-suppression gastric balloon deployment device/set
CARTRIDGE, STAMPED (ETO STERILE SGL)
ANIMAS CORPORATION
10012402
Not in Commercial Distribution

  • 10840406100129 ()
  • 10840406100136 ()
  • 10840406100174 ()
10012402

  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Gastric Band Sutureless Port and Applier
Obtech Medical Sàrl
RLZPT2
Not in Commercial Distribution

  • 30705036004015 ()
  • 20705036004018 ()
RLZPT2

  • Gastric band access port kit
Curved Adjustable Gastric Band with Sutureless Port and Applier
Obtech Medical Sàrl
RLZB32
Not in Commercial Distribution

  • 30705036004008 ()
  • 20705036004001 ()
RLZB32

  • Gastric band
OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON® Accessory Kit - Ejectors
Reshape Lifesciences Inc.
9410-0001
Not in Commercial Distribution

  • 10859810006224 ()
  • 00859810006227 ()


  • Appetite-suppression gastric balloon deployment device/set
  • Appetite-suppression gastric balloon
Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493952838400
In Commercial Distribution

  • 08714729845041 ()

  • 38 mm Stent Length
  • 4.00 mm Stent Diameter
H7493952838400

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
  • Coronary angioplasty balloon catheter, basic
Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493952838350
In Commercial Distribution

  • 08714729845034 ()

  • 3.50 mm Stent Diameter
  • 38 mm Stent Length
H7493952838350

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493952838300
In Commercial Distribution

  • 08714729845027 ()

  • 3.00 mm Stent Diameter
  • 38 mm Stent Length
H7493952838300

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493952838270
In Commercial Distribution

  • 08714729845010 ()

  • 38 mm Stent Length
  • 2.75 mm Stent Diameter
H7493952838270

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