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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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SurVeil DCB - 00812339030340

SurVeil DCB 4.0mm x 60mm x 135cm
Surmodics, Inc.
SRV03513504060
In Commercial Distribution

  • 00812339030340 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

SurVeil DCB - 00812339030333

SurVeil DCB 4.0mm x 40mm x 135cm
Surmodics, Inc.
SRV03513504040
In Commercial Distribution

  • 00812339030333 ()

  • Balloon Diameter: 4 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

Black Diamond Pedicle Screw System - B06210101060

NEEDLE NOSE TAB BREAKERS, BLK DIAMOND
Osseus Fusion Systems, LLC
1010-1060
In Commercial Distribution

  • B06210101060 ()
1010-1060

  • Surgical flat-nosed pliers

Stellarex - 00813132026981

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 135cm
Spectranetics Corporation
AB35SX060200135
In Commercial Distribution

  • 00813132026981 ()

  • Catheter Length: 135 Centimeter
  • Balloon Length: 200 Millimeter
  • Balloon Diameter: 6 Millimeter
AB35SX060200135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026974

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 150mm) x 135cm
Spectranetics Corporation
AB35SX060150135
In Commercial Distribution

  • 00813132026974 ()

  • Catheter Length: 135 Centimeter
  • Balloon Length: 150 Millimeter
  • Balloon Diameter: 6 Millimeter
AB35SX060150135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026967

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 200mm) x 135cm
Spectranetics Corporation
AB35SX050200135
In Commercial Distribution

  • 00813132026967 ()

  • Catheter Length: 135 Centimeter
  • Balloon Length: 200 Millimeter
  • Balloon Diameter: 5 Millimeter
AB35SX050200135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026950

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 150mm) x 135cm
Spectranetics Corporation
AB35SX050150135
In Commercial Distribution

  • 00813132026950 ()

  • Catheter Length: 135 Centimeter
  • Balloon Length: 150 Millimeter
  • Balloon Diameter: 5 Millimeter
AB35SX050150135

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026707

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 150mm) x 80cm
Spectranetics Corporation
AB35SX040150080
In Commercial Distribution

  • 00813132026707 ()

  • Catheter Length: 80 Centimeter
  • Balloon Length: 150 Millimeter
  • Balloon Diameter: 4 Millimeter
AB35SX040150080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026691

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 200mm) x 80cm
Spectranetics Corporation
AB35SX040200080
In Commercial Distribution

  • 00813132026691 ()

  • Catheter Length: 80 Centimeter
  • Balloon Length: 200 Millimeter
  • Balloon Diameter: 4 Millimeter
AB35SX040200080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132026622

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 150mm) x 80cm
Spectranetics Corporation
AB35SX050150080
In Commercial Distribution

  • 00813132026622 ()

  • Catheter Length: 80 Centimeter
  • Balloon Length: 150 Millimeter
  • Balloon Diameter: 5 Millimeter
AB35SX050150080

  • Peripheral angioplasty balloon catheter, drug-coated
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