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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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Vertex - 00810005661065

Implant is 16mm bridge staple, 16mm x 16mm legs. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
STK-16-16-16
In Commercial Distribution

  • 00810005661065 ()

  • Length: 16 Millimeter
  • Depth: 16 Millimeter


  • Orthopaedic bone staple, non-adjustable

Vertex - 00810005661058

Implant is 16mm bridge staple, 14mm x 14mm legs. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
STK-16-14-14
In Commercial Distribution

  • 00810005661058 ()

  • Length: 16 Millimeter
  • Depth: 14 Millimeter


  • Orthopaedic bone staple, non-adjustable

Vertex - 00810005661041

Implant is 14mm bridge staple, 14mm x 14mm legs. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
STK-14-14-14
In Commercial Distribution

  • 00810005661041 ()

  • Length: 14 Millimeter
  • Depth: 14 Millimeter


  • Orthopaedic bone staple, non-adjustable

Vertex - 00810005661034

Implant is 12mm bridge staple, 12mm x 12mm legs. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
STK-12-12-12
In Commercial Distribution

  • 00810005661034 ()

  • Length: 12 Millimeter
  • Depth: 12 Millimeter


  • Orthopaedic bone staple, non-adjustable

Vertex - 00810005661027

Implant is 10mm bridge staple, 10mm x 10mm legs. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
STK-10-10-10
In Commercial Distribution

  • 00810005661027 ()

  • Length: 10 Millimeter
  • Depth: 10 Millimeter


  • Orthopaedic bone staple, non-adjustable

Vertex - 00810005661010

Implant is 8mm bridge staple, 8mm x 8mm legs. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
STK-08-08-08
In Commercial Distribution

  • 00810005661010 ()

  • Length: 8 Millimeter
  • Depth: 8 Millimeter


  • Orthopaedic bone staple, non-adjustable

Lap-port closure device guides 5mm and 10/12 mm Reusable - B354OSLPCDGR510120

Lap-port closure device guides 5mm and 10/12 mm Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDGR510/12
In Commercial Distribution

  • B354OSLPCDGR510120 ()
OSLPCDGR

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use

Lap-port closure device guides 10/12mm and 15 mm Bariatric Reusable - B354OSLPCDGBR0

Lap-port closure device guides 10/12mm and 15 mm Bariatric Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDGBR
In Commercial Distribution

  • B354OSLPCDGBR0 ()
OSLPCDGBR

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread

elements IC - 08809455602393

The cordless elements IC obturation system combines a Downpack heat source with a Backfill extruder. The Downpack device provides fast heating of the heat plugger with precisely controlled temperature and timing, making it suitable for single-motion downpack obturation of the apical portion of the root canal. Utilizing single-use gutta-percha cartridges, the ergonomic Backfill device has a motorized extruder system for precise temperature and speed control for a 3-dimensional obturation of the root canal system.
META SYSTEMS CO., LTD.
elements IC DOWNPACK UNIT
In Commercial Distribution

  • 08809455602393 ()
973-0602-TYPEB

  • Endodontic obturation system

elements IC - 08809455602386

The cordless elements IC obturation system combines a Downpack heat source with a Backfill extruder. The Downpack device provides fast heating of the heat plugger with precisely controlled temperature and timing, making it suitable for single-motion downpack obturation of the apical portion of the root canal. Utilizing single-use gutta-percha cartridges, the ergonomic Backfill device has a motorized extruder system for precise temperature and speed control for a 3-dimensional obturation of the root canal system.
META SYSTEMS CO., LTD.
elements IC SYSTEM
In Commercial Distribution

  • 08809455602386 ()
973-0600-TYPEB

  • Endodontic obturation system
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