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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No Description
Biomet Orthopedics, LLC
8153-04-065
In Commercial Distribution

  • 00887868041068 ()

  • 4.0MM X 65MM
815304065

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
Biomet Orthopedics, LLC
8153-04-060
In Commercial Distribution

  • 00887868041051 ()

  • 4.0MM X 60MM
815304060

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
Biomet Orthopedics, LLC
8153-04-055
In Commercial Distribution

  • 00887868041044 ()

  • 4.0MM X 55MM
815304055

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
Biomet Orthopedics, LLC
8153-04-050
In Commercial Distribution

  • 00887868041037 ()

  • 4.0MM X 50MM
815304050

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
NDD Medizintechnik AG
2091-422
In Commercial Distribution

  • 07640142190899 ()


  • Pulmonary function testing filter/mouthpiece
No Description
NDD Medizintechnik AG
2030-21
In Commercial Distribution

  • 07640142190578 ()
  • 07640142190615 ()


  • Pulmonary function testing filter/mouthpiece
Removal Driver 4.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-9045
In Commercial Distribution

  • 00819034023158 ()
CD-FT-9045

  • Screw-extraction orthopaedic reamer, single-use
Removal Driver 3.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-9035
In Commercial Distribution

  • 00819034023141 ()
CD-FT-9035

  • Screw-extraction orthopaedic reamer, single-use
Removal Driver 2.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-9025
In Commercial Distribution

  • 00819034023134 ()
CD-FT-9025

  • Screw-extraction orthopaedic reamer, single-use
Torx Driver 4.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-3045
In Commercial Distribution

  • 00819034023127 ()
CD-FT-3045

  • Surgical screwdriver, single-use, non-sterile
Torx Driver 3.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-3035
In Commercial Distribution

  • 00819034023110 ()
CD-FT-3035

  • Surgical screwdriver, single-use, non-sterile
Torx Driver 2.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-3025
In Commercial Distribution

  • 00819034023103 ()
CD-FT-3025

  • Surgical screwdriver, single-use, non-sterile
Cannulated Reamer 4.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-2045
In Commercial Distribution

  • 00819034023097 ()
CD-FT-2045

  • Surgical countersink, single-use
Cannulated Reamer 3.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-2035
In Commercial Distribution

  • 00819034023080 ()
CD-FT-2035

  • Surgical countersink, single-use
Cannulated Reamer 2.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-2025
In Commercial Distribution

  • 00819034023073 ()
CD-FT-2025

  • Surgical countersink, single-use
Calibrated Drill Cannulated 3.0mm
FUSION ORTHOPEDICS, LLC
CD-FT-1030
In Commercial Distribution

  • 00819034023066 ()
CD-FT-1030

  • Cannulated surgical drill bit, single-use, non-sterile
Calibrated Drill Cannulated 2.1mm
FUSION ORTHOPEDICS, LLC
CD-FT-1021
In Commercial Distribution

  • 00819034023059 ()
CD-FT-1021

  • Cannulated surgical drill bit, single-use, non-sterile
Calibrated Drill Cannulated 1.7mm
FUSION ORTHOPEDICS, LLC
CD-FT-1017
In Commercial Distribution

  • 00819034023042 ()
CD-FT-1017

  • Cannulated surgical drill bit, single-use, non-sterile
The Minisilk-FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200nm. Emission activation is by footswitch. Overall weight of the system is 16kg, and the size is 22x37x45cm (HxWxD). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.
EL.EN. SPA
M081R1
In Commercial Distribution

  • 08057017760337 ()
M081R1

  • Multi-modality skin contouring system
K-Wire Threaded 1.4mm
FUSION ORTHOPEDICS, LLC
CD-FX-0014
In Commercial Distribution

  • 00819034028344 ()
CD-FX-0014

  • Orthopaedic bone wire
K-Wire Standard 1.4mm
FUSION ORTHOPEDICS, LLC
CD-FX-0014
In Commercial Distribution

  • 00819034028337 ()
CD-FX-0014

  • Orthopaedic bone wire
Tissue Protector 3.5mm
FUSION ORTHOPEDICS, LLC
TN-FT-9135
In Commercial Distribution

  • 00840124506664 ()
TN-FT-9135

  • Orthopaedic implantation sleeve, reusable
Tissue Protector 4.5mm
FUSION ORTHOPEDICS, LLC
TN-FT-9145
In Commercial Distribution

  • 00840124506657 ()
TN-FT-9145

  • Orthopaedic implantation sleeve, reusable
Tissue Protector 2.5mm
FUSION ORTHOPEDICS, LLC
TN-FT-9125
In Commercial Distribution

  • 00840124506640 ()
TN-FT-9125

  • Orthopaedic implantation sleeve, reusable
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
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
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
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
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 for Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M004390008P0
In Commercial Distribution

  • 08714729877998 ()

  • 185 cm Length
  • 6 ft Length


  • Electrical-only medical device connection cable, reusable
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