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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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Elation 5™ - 00884450383483

No Description
Merit Medical Systems, Inc.
00884450383483
In Commercial Distribution

  • 00884450383483 ()

  • Balloon Length-8 cm
  • Catheter Length-180 cm
  • Balloon Outer Diameters-7 mm, 8 mm, 9 mm, 10 mm, 11 mm
EX8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450383452

No Description
Merit Medical Systems, Inc.
00884450383452
In Commercial Distribution

  • 10884450383459 ()
  • 00884450383452 ()

  • Catheter Length-180 cm
  • Balloon Outer Diameters-14 mm, 15 mm, 16.5 mm, 18 mm, 19 mm
  • Balloon Length-8 cm
EX15

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450383438

No Description
Merit Medical Systems, Inc.
00884450383438
In Commercial Distribution

  • 10884450383435 ()
  • 00884450383438 ()

  • Balloon Length-8 cm
  • Balloon Outer Diameters-9 mm, 10 mm, 11 mm, 12 mm, 13 mm
  • Catheter Length-180 cm
EX10

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450383476

No Description
Merit Medical Systems, Inc.
00884450383476
In Commercial Distribution

  • 10884450383473 ()
  • 00884450383476 ()

  • Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm
  • Balloon Length-8 cm
  • Catheter Length-180 cm
  • Catheter Length-180 cm; Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm; Balloon Length-8 cm; Catheter Length-180 cm
  • Balloon Length-8 cm; Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm; Balloon Length-8 cm; Catheter Length-180 cm
EX6

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450383469

No Description
Merit Medical Systems, Inc.
00884450383469
In Commercial Distribution

  • 10884450383466 ()
  • 00884450383469 ()

  • Balloon Outer Diameters-17 mm, 18 mm, 19 mm, 20 mm, 21 mm
  • Balloon Length-8 cm
  • Catheter Length-180 cm
EX18

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450383445

No Description
Merit Medical Systems, Inc.
00884450383445
In Commercial Distribution

  • 10884450383442 ()
  • 00884450383445 ()

  • Balloon Outer Diameters-11 mm, 12 mm, 13.5 mm, 15 mm, 16 mm
  • Balloon Length-8 cm
  • Catheter Length-180 cm
EX12

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Itrevia 5 HF-T - 04035479129781

No Description
BIOTRONIK SE & Co. KG
393066
Not in Commercial Distribution

  • 04035479129781 ()
393066

  • Cardiac resynchronization therapy implantable defibrillator

Itrevia 5 HF-T - 04035479129767

No Description
BIOTRONIK SE & Co. KG
393064
Not in Commercial Distribution

  • 04035479129767 ()
393064

  • Cardiac resynchronization therapy implantable defibrillator

Itrevia 5 VR-T - 04035479129743

No Description
BIOTRONIK SE & Co. KG
393059
Not in Commercial Distribution

  • 04035479129743 ()
393059

  • Single-chamber implantable defibrillator

Itrevia 5 VR-T - 04035479129736

No Description
BIOTRONIK SE & Co. KG
393058
Not in Commercial Distribution

  • 04035479129736 ()
393058

  • Single-chamber implantable defibrillator
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