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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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POLYAXPOLYAXIAL SCREW, FT - 00887868041037

No Description
Biomet Orthopedics, LLC
8153-04-050
In Commercial Distribution

  • 00887868041037 ()

  • 4.0MM X 50MM
815304050

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

QuickTalker FT 23 - 00186648000814

The QuickTalker FeatherTouch 23 speech device provides multi-message communication that is highly portable, durable, and easy to use. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate. QuickTalker FeatherTouch 23 includes 103 unique messages available across five recording levels and provides an individual with robust communication options throughout the day.
Ablenet, Inc.
10000038
In Commercial Distribution

  • 00186648000814 ()
10000038

  • Assistive speech generator

QuickTalker FT 12 - 00186648000807

The QuickTalker FeatherTouch 12 speech device provides multi-message communication that is highly portable, durable, and easy to use. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate. QuickTalker FeatherTouch 12 includes 48 unique messages available across five recording levels and provides an individual with robust communication options throughout the day.
Ablenet, Inc.
10000037
In Commercial Distribution

  • 00186648000807 ()
10000037

  • Assistive speech generator

QuickTalker FT 7 - 00186648000791

The QuickTalker FeatherTouch 7 speech device provides multi-message communication that is highly portable, durable, and easy to use. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate. QuickTalker FeatherTouch 7 includes 23 unique messages available across five recording levels and provides an individual with robust communication options throughout the day.
Ablenet, Inc.
10000036
In Commercial Distribution

  • 00186648000791 ()
10000036

  • Assistive speech generator

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
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