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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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PolarCath - B479P4100120010

PolarCath peripheral dilation catheter over the wire 6F . (4.0mm x 100mm, 120cm)
Nucryo Vascular
P410012001
In Commercial Distribution

  • B479P4100120010 ()


  • Peripheral angioplasty balloon catheter, basic

PolarCath - B479NC30000010

PolarCath nitrous oxide cartridge for use with PolarCath peripheral dilation system
Nucryo Vascular
NC3000001
In Commercial Distribution

  • B479NC30000010 ()
  • B479NC30000011 ()


  • Peripheral angioplasty balloon catheter, basic

25ga Internal Delivery Device (IDD) - VS0250251

25ga Internal Delivery Device for use in viscodissection
Vortex Surgical, Inc.
VS0250.25
In Commercial Distribution

  • VS0250251 ()
VS0250.25

  • Vitrectomy fluid/gas handling handpiece/cannula

NANO SubRet Gateway Device - VS02251

28ga Delivery Device for transcleral procedures
Vortex Surgical, Inc.
VS0225
In Commercial Distribution

  • VS02251 ()
VS0225

  • Vitrectomy fluid/gas handling handpiece/cannula

Chocolate PTA Balloon Catheter - M874CF1812060120OTW1

No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812060120OTW1 ()


  • Peripheral angioplasty balloon catheter, basic

Chocolate PTA Balloon Catheter - M874CF1812060080OTW1

No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812060080OTW1 ()


  • Peripheral angioplasty balloon catheter, basic

Chocolate PTA Balloon Catheter - M874CF1812060040OTW1

No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812060040OTW1 ()


  • Peripheral angioplasty balloon catheter, basic

Chocolate PTA Balloon Catheter - M874CF1812060020OTW1

No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812060020OTW1 ()


  • Peripheral angioplasty balloon catheter, basic

Chocolate PTA Balloon Catheter - M874CF1812055120OTW1

No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812055120OTW1 ()


  • Peripheral angioplasty balloon catheter, basic

Chocolate PTA Balloon Catheter - M874CF1812055080OTW1

No Description
TRIREME MEDICAL, LLC
C
In Commercial Distribution

  • M874CF1812055080OTW1 ()


  • Peripheral angioplasty balloon catheter, basic
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