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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Instrument: sizing guide body is 12-14 (multiple use). 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-1000T-002
In Commercial Distribution

  • 00810005667289 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: sizing guide body is 20-25 (multiple use). 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-1000T-004
In Commercial Distribution

  • 00810005667272 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: sizing guide body is 16-18 (multiple use). 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-1000T-003
In Commercial Distribution

  • 00810005667265 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: sizing guide body is 08-10 (multiple use). 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-1000T-001
In Commercial Distribution

  • 00810005667258 ()


  • General internal orthopaedic fixation system implantation kit
Implant is 20mm bridge staple, 20mm x 20mm 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-20-20-20
In Commercial Distribution

  • 00810005665162 ()

  • Length: 20 Millimeter
  • Depth: 20 Millimeter


  • Orthopaedic bone staple, non-adjustable
Implant is 20mm bridge staple, 18mm x 18mm 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-20-18-18
In Commercial Distribution

  • 00810005665155 ()

  • Length: 20 Millimeter
  • Depth: 18 Millimeter


  • Orthopaedic bone staple, non-adjustable
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
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
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
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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