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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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CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F30020MR
In Commercial Distribution

  • 04540778157491 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 3.0 mm
BD-F30020MR

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F25020MR
In Commercial Distribution

  • 04540778157477 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.5 mm
BD-F25020MR

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F20020MR
In Commercial Distribution

  • 04540778157453 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 20 mm
  • Balloon Diameter; 2.0 mm
BD-F20020MR

  • Peripheral angioplasty balloon catheter, basic
The VT300 is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VT300 (5150)
In Commercial Distribution

  • 00858340006363 ()


  • X-ray film cassette holder
The VT300 is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VT300 (5157)
In Commercial Distribution

  • 00858340006356 ()


  • X-ray film cassette holder
The VS300 is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VS300
In Commercial Distribution

  • 00858340006349 ()


  • X-ray film cassette holder
The VS100 is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VS100
In Commercial Distribution

  • 00858340006332 ()


  • X-ray film cassette holder
The VT300T is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VT300T
In Commercial Distribution

  • 00858340006141 ()


  • X-ray film cassette holder
Accell TBM, 7 cm diameter - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-760
In Commercial Distribution

  • M3860240007601 ()
  • 10889981055660 ()

  • 7cm Round
02-4000-760

  • Bone matrix implant, human-derived
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
Acera Surgical Inc
C1-5X7
In Commercial Distribution

  • 00854258006051 ()

  • Length: 17.5 Centimeter
  • Width: 12.5 Centimeter
  • Length: 7 Inch
  • Width: 5 Inch


  • Dura mater graft, synthetic
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