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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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GETINGE 46-SERIES - 07340153710146

WASHER DISINFECTOR 46-5 S+W D, S+W D indicating a single door washer disinfector with dryer. This is a customized version of 46-5-402 with water inlet through the roof plate and signal exchange for external valve for treated water.
Getinge Disinfection AB
46-5
In Commercial Distribution

  • 07340153710146 ()
46-5-402K962

  • Surgical utensil washer/disinfector

Javelin - 00810005665674

3.00mm dia 16mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-16N
In Commercial Distribution

  • 00810005665674 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 16 Millimeter


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

Javelin - 00810005665667

3.00mm dia 14mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-14N
In Commercial Distribution

  • 00810005665667 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 14 Millimeter


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

Javelin - 00810005665650

3.00mm dia 12mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-12N
In Commercial Distribution

  • 00810005665650 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 12 Millimeter


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

Javelin - 00810005665643

3.00mm dia 10mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-10N
In Commercial Distribution

  • 00810005665643 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 10 Millimeter


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

Javelin - 00810005665636

3.00mm dia 8mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-08N
In Commercial Distribution

  • 00810005665636 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 8 Millimeter


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

Javelin - 00810005665629

3.00mm dia 6mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-06N
In Commercial Distribution

  • 00810005665629 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 6 Millimeter


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

Javelin - 00810005665612

2.40mm dia 16mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-16N
In Commercial Distribution

  • 00810005665612 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 16 Millimeter


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

Javelin - 00810005665605

2.40mm dia 14mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-14N
In Commercial Distribution

  • 00810005665605 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 14 Millimeter


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

Javelin - 00810005665599

2.40mm dia 12mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-12N
In Commercial Distribution

  • 00810005665599 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 12 Millimeter


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