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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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OCS Heart Gas Cylinder, Refill
TRANSMEDICS, INC.
1406
In Commercial Distribution

  • B00924420 ()
  • B00924423 ()

  • Length: 18 Inch
  • Width: 4 Inch
  • Height: 4 Inch
1406

  • Donor-organ preservation/transport system gas refillable cylinder
OCS Heart Gas Cylinder
TRANSMEDICS, INC.
1406
In Commercial Distribution

  • B00913600 ()
  • B00913603 ()

  • Length: 18 Inch
  • Width: 4 Inch
  • Height: 4 Inch
1406

  • Donor-organ preservation/transport system gas refillable cylinder
The MAG is an electro-mechanical ablation system that utilizes both monopolar and bipolar radio frequency (RF) energy to ablate biological tissue. The MAG can be used with a variety of AtriCure Handpieces to perform cardiac ablations.
ATRICURE, INC.
MAG
In Commercial Distribution

  • 10840143900044 ()
  • 30840143904473 ()
A001372

  • Cardiac radio-frequency ablation system generator
OCS Heart Solution Set
TRANSMEDICS, INC.
1300
In Commercial Distribution

  • B00926340 ()
  • B00926341 ()

  • Length: 20 Inch
  • Width: 15 Inch
  • Height: 3 Inch
1300

  • Donor-organ/tissue/cell preservation solution
The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the set screws that secure the leads to the Rechargeable Neuroregulator.
Reshape Lifesciences Inc.
1680
Not in Commercial Distribution

  • 00857334004248 ()

  • Length: 1.685 Inch
  • Outer Diameter: 0.218 Inch
1680

  • Surgical torque wrench, reusable
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS465
Not in Commercial Distribution

  • 08595231700062 ()
  • 08595231704657 ()
  • 08595231700055 ()

  • Length: 65 Millimeter
  • Outer Diameter: 4 Millimeter


  • Hygroscopic cervical dilator
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS455
Not in Commercial Distribution

  • 08595231700048 ()
  • 08595231704558 ()
  • 08595231700031 ()

  • Length: 55 Millimeter
  • Outer Diameter: 4 Millimeter


  • Hygroscopic cervical dilator
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive, and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
MEDICEM Technology s.r.o.
DS355
Not in Commercial Distribution

  • 08595231703551 ()
  • 08595231700024 ()
  • 08595231700017 ()

  • Outer Diameter: 3 Millimeter
  • Length: 55 Millimeter


  • Hygroscopic cervical dilator
Premounted Stent System
BOSTON SCIENTIFIC CORPORATION
H74938047160130
In Commercial Distribution

  • 08714729392392 ()

  • 57 mm Stent Length
  • 10 mm Diameter
  • 135 cm Effective Length
H74938047160130

  • Iliac artery stent, bare-metal
Premounted Stent System
BOSTON SCIENTIFIC CORPORATION
H74938047140130
In Commercial Distribution

  • 08714729392385 ()

  • 10 mm Diameter
  • 135 cm Effective Length
  • 37 mm Stent Length
H74938047140130

  • Iliac artery stent, bare-metal
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