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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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FuzeFix Max FT - 00840124506664

Tissue Protector 3.5mm
FUSION ORTHOPEDICS, LLC
TN-FT-9135
In Commercial Distribution

  • 00840124506664 ()
TN-FT-9135

  • Orthopaedic implantation sleeve, reusable

FuzeFix Max FT - 00840124506657

Tissue Protector 4.5mm
FUSION ORTHOPEDICS, LLC
TN-FT-9145
In Commercial Distribution

  • 00840124506657 ()
TN-FT-9145

  • Orthopaedic implantation sleeve, reusable

FuzeFix Max FT - 00840124506640

Tissue Protector 2.5mm
FUSION ORTHOPEDICS, LLC
TN-FT-9125
In Commercial Distribution

  • 00840124506640 ()
TN-FT-9125

  • Orthopaedic implantation sleeve, reusable

HomeChoice PRO APD System - 00085412026350

The HomeChoice PRO Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
BAXTER INTERNATIONAL INC.
5C8310R
In Commercial Distribution

  • 00085412026350 ()
5C8310R

  • Peritoneal dialysis system

HomeChoice APD System - 00085412007021

The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
BAXTER INTERNATIONAL INC.
5C4471
In Commercial Distribution

  • 00085412007021 ()
5C4471

  • Peritoneal dialysis system

Cable, IntellaNav™ Ablation Catheter - 08714729848783

Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M004RARC010
In Commercial Distribution

  • 08714729848783 ()

  • 200 cm Length
  • 6.6 ft Length
M004RARC010

  • Electrical-only medical device connection cable, reusable

Cable, Orbiter™ PV - 08714729877998

Cable for Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M004390008P0
In Commercial Distribution

  • 08714729877998 ()

  • 185 cm Length
  • 6 ft Length


  • Electrical-only medical device connection cable, reusable

Cable, Orbiter™ ST - 08714729877981

Cable for Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M004390004P0
Not in Commercial Distribution

  • 08714729877981 ()

  • 7 ft Length
  • 210 cm Length


  • Electrical-only medical device connection cable, reusable

Cable, Orbiter™ ST - 08714729877974

Cable for Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M004390003P0
Not in Commercial Distribution

  • 08714729877974 ()

  • 4 ft Length
  • 125 cm Length


  • Electrical-only medical device connection cable, reusable

Cable, IntellaTip MiFi™ OI - 08714729877424

Sterile Cable
BOSTON SCIENTIFIC CORPORATION
M0046270
In Commercial Distribution

  • 08714729877424 ()

  • 10 ft Length
  • 305 cm Length
M0046270

  • Electrical-only medical device connection cable, reusable
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