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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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PCM - 00887517081605

Artificial Vertebral Disc, 8.0 mm Large
Nuvasive, Inc.
7680480
In Commercial Distribution

  • 00887517081605 ()

  • Depth: 17 Millimeter
  • Width: 20 Millimeter
  • Height: 8 Millimeter


  • Cervical total intervertebral disc prosthesis, modular

PCM - 00887517081193

Artificial Vertebral Disc, 7.2 mm Large
Nuvasive, Inc.
7680472
In Commercial Distribution

  • 00887517081193 ()

  • Depth: 17 Millimeter
  • Width: 20 Millimeter
  • Height: 7.2 Millimeter


  • Cervical total intervertebral disc prosthesis, modular

PCM - 00887517081186

Artificial Vertebral Disc, 6.5 mm Large
Nuvasive, Inc.
7680465
In Commercial Distribution

  • 00887517081186 ()

  • Depth: 17 Millimeter
  • Width: 20 Millimeter
  • Height: 6.5 Millimeter


  • Cervical total intervertebral disc prosthesis, modular

OCS Heart System - B00926340

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

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135446

Lutonix® AV Drug Coated Balloon PTA Catheter 8x20x75
LUTONIX, INC.
LX3575820V
In Commercial Distribution

  • 00801741135446 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 8millimeter
  • Catheter Length, 75 centimeter
LX3575820V

  • Peripheral angioplasty balloon catheter, drug-coated

TALENT® OCCLUDER - 00763000233778

STENT GRAFT OCL20US 20MM OCCLUDER
MEDTRONIC, INC.
OCL20US
Not in Commercial Distribution

  • 00763000233778 ()

  • Stent Graft Diameter 20 MM
  • Stent Graft Covered Length 35 MM


  • Abdominal aorta endovascular stent-graft

IDEAL IMPLANT - 10851795006138

Round, smooth-surface, saline-filled breast implant.
IDEAL IMPLANT INCORPORATED
67501
In Commercial Distribution

  • 10851795006138 ()

  • Total Volume, 675 cc
675

  • Saline-filled breast implant, unstructured

IDEAL IMPLANT - 10851795006121

Round, smooth-surface, saline-filled breast implant.
IDEAL IMPLANT INCORPORATED
63501
In Commercial Distribution

  • 10851795006121 ()

  • Total Volume, 635 cc
635

  • Saline-filled breast implant, unstructured

IDEAL IMPLANT - 10851795006114

Round, smooth-surface, saline-filled breast implant.
IDEAL IMPLANT INCORPORATED
59501
In Commercial Distribution

  • 10851795006114 ()

  • Total Volume, 595 cc
595

  • Saline-filled breast implant, unstructured

IDEAL IMPLANT - 10851795006107

Round, smooth-surface, saline-filled breast implant.
IDEAL IMPLANT INCORPORATED
55501
In Commercial Distribution

  • 10851795006107 ()

  • Total Volume, 555 cc
555

  • Saline-filled breast implant, unstructured
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