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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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SUMMIT MEDICAL - 00385640064927

No Description
Summit Medical, Inc.
AFTD-Y
In Commercial Distribution

  • 10385640064924 ()
  • 00385640064927 ()
  • 00859898006065 ()


  • Surgical irrigation tubing set, single-use

BeBack Crossing Catheter - 04260279096470

The BeBack Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures. The BeBack Crossing Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions oft he peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The BeBack Crossing Catheter is available with outer diameters of 4 F (1.4 mm) or 2.9 F (0.96 mm), accommodate 0.018“ or 0.014“ guidewires accordingly, and both diameters have effective lengths of 80 cm or 120 cm.
Bentley InnoMed GmbH
4 F, 80 cm
In Commercial Distribution


  • Introducer Sheath Compatibility: 4 French
  • Catheter Length: 80 Centimeter
GB-600-US-018P-80L

  • Peripheral vascular intervention infusion catheter

BeBack Crossing Catheter - 04260279096463

The BeBack Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures. The BeBack Crossing Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions oft he peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The BeBack Crossing Catheter is available with outer diameters of 4 F (1.4 mm) or 2.9 F (0.96 mm), accommodate 0.018“ or 0.014“ guidewires accordingly, and both diameters have effective lengths of 80 cm or 120 cm.
Bentley InnoMed GmbH
2.9 F, 120 cm
In Commercial Distribution


  • Introducer Sheath Compatibility: 2.9 French
  • Catheter Length: 120 Centimeter
GB-603-US-014P-120L

  • Peripheral vascular intervention infusion catheter

Cross-Fuse PEEK IBF System - 00846468035891

22X55X9MM 6 DEGREE CROSSFUSE IMPLANTS
Pioneer Surgical Technology, Inc.
35-2255-9-6
Not in Commercial Distribution

35-2255-9-6

  • Vertebral body prosthesis

Cross-Fuse PEEK IBF System - 00846468035884

22X55X9MM CROSSFUSE IMPLANTS
Pioneer Surgical Technology, Inc.
35-2255-9
Not in Commercial Distribution

35-2255-9

  • Vertebral body prosthesis

Cross-Fuse PEEK IBF System - 00846468035877

22X55X15MM 6 DEGREE CROSSFUSE IMPLANTS
Pioneer Surgical Technology, Inc.
35-2255-15-6
Not in Commercial Distribution

35-2255-15-6

  • Vertebral body prosthesis

Cross-Fuse PEEK IBF System - 00846468035860

22X55X15MM CROSSFUSE IMPLANTS
Pioneer Surgical Technology, Inc.
35-2255-15
Not in Commercial Distribution

35-2255-15

  • Vertebral body prosthesis

Cross-Fuse PEEK IBF System - 00846468035853

22X55X13MM 6 DEGREE CROSSFUSE IMPLANTS
Pioneer Surgical Technology, Inc.
35-2255-13-6
Not in Commercial Distribution

35-2255-13-6

  • Vertebral body prosthesis

Cross-Fuse PEEK IBF System - 00846468035846

22X55X13MM CROSSFUSE IMPLANTS
Pioneer Surgical Technology, Inc.
35-2255-13
Not in Commercial Distribution

35-2255-13

  • Vertebral body prosthesis

Cross-Fuse PEEK IBF System - 00846468035839

22X55X11MM 6 DEGREE CROSSFUSE IMPLANTS
Pioneer Surgical Technology, Inc.
35-2255-11-6
Not in Commercial Distribution

35-2255-11-6

  • Vertebral body prosthesis
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