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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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Healix - 00810005666916

Cann. Headed Screw 2.5mmD, 28mmL 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.
CH-25-28
In Commercial Distribution

  • 00810005666916 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 28 Millimeter


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

Healix - 00810005666909

Stylet for 2.0 - 2.5 Screws. 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-601
In Commercial Distribution

  • 00810005666909 ()


  • General internal orthopaedic fixation system implantation kit

Healix - 00810005666893

Stylet for 4.0 - 5.5 Screws. 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-603
In Commercial Distribution

  • 00810005666893 ()


  • General internal orthopaedic fixation system implantation kit

Healix - 00810005666886

Stylet for 6.0 - 8.5 Screws. 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-604
In Commercial Distribution

  • 00810005666886 ()


  • General internal orthopaedic fixation system implantation kit

Healix - 00810005666701

Kwire Trocar 6.0mm - 8.5mm Threaded. 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-351
In Commercial Distribution

  • 00810005666701 ()


  • Orthopaedic bone wire

Healix - 00810005666695

Kwire Trocar 6.0mm - 8.5mm. 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-350
In Commercial Distribution

  • 00810005666695 ()


  • Orthopaedic bone wire

Healix - 00810005666688

Kwire Trocar 5.0mm - 5.5mm. 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-340
In Commercial Distribution

  • 00810005666688 ()


  • Orthopaedic bone wire

Healix - 00810005666534

Screw Inserter 4.0-4.5 (T10). 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-060
In Commercial Distribution

  • 00810005666534 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Healix - 00810005666527

Screw Inserter 3.0-3.5 (T8). 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-040
In Commercial Distribution

  • 00810005666527 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Healix - 00810005666442

Cannul. Depth Gauge Long, 230mm. 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-201
In Commercial Distribution

  • 00810005666442 ()


  • Surgical depth gauge, reusable
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