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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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Instrument: Depth Gauge tool. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-1001T-DPG
In Commercial Distribution

  • 00810005663854 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Olive Pin. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-1000T-OPIN
In Commercial Distribution

  • 00810005663847 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Screw Inserter. 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-1000T-ISRT
In Commercial Distribution

  • 00810005662864 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
T6 Multi-Drive Inserter. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CSRW-1000T-021
In Commercial Distribution

  • 00810005662833 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Dissector
MIZUHO AMERICA, INC.
07-CVM-31
In Commercial Distribution

  • 00810009464624 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-30
In Commercial Distribution

  • 00810009464617 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-29
In Commercial Distribution

  • 00810009464600 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-28
In Commercial Distribution

  • 00810009464594 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-27
In Commercial Distribution

  • 00810009464587 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-26
In Commercial Distribution

  • 00810009464570 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-25
In Commercial Distribution

  • 00810009464563 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-24
In Commercial Distribution

  • 00810009464556 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-22
In Commercial Distribution

  • 00810009464532 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-20
In Commercial Distribution

  • 00810009464518 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-18
In Commercial Distribution

  • 00810009464495 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-17
In Commercial Distribution

  • 00810009464488 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-16
In Commercial Distribution

  • 00810009464471 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-14
In Commercial Distribution

  • 00810009464457 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-12
In Commercial Distribution

  • 00810009464433 ()


  • Open-surgery dissector
Dissector
MIZUHO AMERICA, INC.
07-CVM-11
In Commercial Distribution

  • 00810009464426 ()


  • Open-surgery dissector
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