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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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BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm 5 French
LUTONIX, INC.
BSLX35754605F
Not in Commercial Distribution

  • 00801741123344 ()

  • Balloon Length, 60 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
BSLX35754605F

  • Peripheral angioplasty balloon catheter, drug-coated
BSC LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm 5 French
LUTONIX, INC.
BSLX35754405F
Not in Commercial Distribution

  • 00801741123337 ()

  • Balloon Length, 40 Millimeter
  • Catheter Length, 75 Centimeter
  • Balloon Diameter, 4 Millimeter
BSLX35754405F

  • Peripheral angioplasty balloon catheter, drug-coated
Avitene Ultrafoam, 8 cm x 12.5 cm (3-1/8" x 5"), 100 sq cm
Davol Inc.
1050040
In Commercial Distribution

  • 10801741010542 ()
  • 00801741010545 ()

  • Depth: 1 Centimeter
  • Width: 8 Centimeter
  • Length: 12.5 Centimeter
1050040

  • Collagen haemostatic agent, non-antimicrobial
No Description
SRS Medical Systems, Inc.
The Spanner Stent Size 5
In Commercial Distribution

  • 00890477000012 ()


  • Polymeric urethral stent, short-term
LIFESTENT® 5F Vascular Stent System, 5 mm x 150 mm (80 cm delivery catheter)
Bard Peripheral Vascular, Inc.
5F051501CS
In Commercial Distribution

  • 00801741120886 ()

  • Implant Diameter, 5 Millimeter
  • Implant Length, 150 Millimeter
  • Catheter Length, 80 Centimeter
  • Minimum Introducer Size, 5 French
5F051501CS

  • Peripheral artery stent, bare-metal
LIFESTENT® 5F Vascular Stent System, 5 mm x 170 mm (135 cm delivery catheter)
Bard Peripheral Vascular, Inc.
5F051703CS
In Commercial Distribution

  • 00801741120671 ()

  • Implant Diameter, 5 Millimeter
  • Catheter Length, 135 Centimeter
  • Minimum Introducer Size, 5 French
  • Implant Length, 170 Millimeter
5F051703CS

  • Peripheral artery stent, bare-metal
LIFESTENT® 5F Vascular Stent System, 5 mm x 150 mm (135 cm delivery catheter)
Bard Peripheral Vascular, Inc.
5F051503CS
In Commercial Distribution

  • 00801741120664 ()

  • Implant Length, 150 Millimeter
  • Minimum Introducer Size, 5 French
  • Catheter Length, 135 Centimeter
  • Implant Diameter, 5 Millimeter
5F051503CS

  • Peripheral artery stent, bare-metal
LIFESTENT® 5F Vascular Stent System, 5 mm x 120 mm (135 cm delivery catheter)
Bard Peripheral Vascular, Inc.
5F051203CS
In Commercial Distribution

  • 00801741120657 ()

  • Catheter Length, 135 Centimeter
  • Implant Diameter, 5 Millimeter
  • Minimum Introducer Size, 5 French
  • Implant Length, 120 Millimeter
5F051203CS

  • Peripheral artery stent, bare-metal
LIFESTENT® 5F Vascular Stent System, 5 mm x 100 mm (135 cm delivery catheter)
Bard Peripheral Vascular, Inc.
5F051003CS
In Commercial Distribution

  • 00801741120640 ()

  • Implant Length, 100 Millimeter
  • Implant Diameter, 5 Millimeter
  • Catheter Length, 135 Centimeter
  • Minimum Introducer Size, 5 French
5F051003CS

  • Peripheral artery stent, bare-metal
LIFESTENT® 5F Vascular Stent System, 5 mm x 80 mm (135 cm delivery catheter)
Bard Peripheral Vascular, Inc.
5F050803CS
In Commercial Distribution

  • 00801741120633 ()

  • Implant Length, 80 Millimeter
  • Catheter Length, 135 Centimeter
  • Minimum Introducer Size, 5 French
  • Implant Diameter, 5 Millimeter
5F050803CS

  • Peripheral artery stent, bare-metal
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