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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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Intended to be used for the insertion of spinal implants and trials into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
LET30310T
In Commercial Distribution

  • 09421028116428 ()
LET30310T

  • Orthopaedic inorganic implant inserter/extractor, reusable
A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
000-0563
In Commercial Distribution

  • 09421028116343 ()
000-0563

  • Orthopaedic prosthesis implantation positioning instrument, reusable
A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4250-7025
In Commercial Distribution

  • 09421028113311 ()
  • 09421028113304 ()
4250-7025

  • Surgical power tool adaptor
A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4250-7020
In Commercial Distribution

  • 09421028113311 ()
  • 09421028113298 ()
4250-7020

  • Surgical power tool adaptor
A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4250-7010
In Commercial Distribution

  • 09421028113311 ()
  • 09421028113281 ()
4250-7010

  • Surgical power tool adaptor
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4252-2061
In Commercial Distribution

  • 09421028111904 ()
4252-2061

  • Orthopaedic implant impactor, reusable
NAVIGATOR® CERTAIN® IMPLANT MOUNT, 3.4MM(D) X 4(L)
BIOMET 3I, LLC
MSGIIM4
In Commercial Distribution

  • 00844868010524 ()

  • Diameter 3.4 mm
  • Length: 4 Millimeter


  • Surgical screwdriver, reusable
NAVIGATOR® CERTAIN® IMPLANT MOUNT, 3.4MM(D) X 3(L)
BIOMET 3I, LLC
MSGIIM3
In Commercial Distribution

  • 00844868010517 ()

  • Length: 3 Millimeter
  • Diameter 3.4 mm


  • Surgical screwdriver, reusable
NAVIGATOR® CERTAIN® IMPLANT MOUNT, 3.4MM(D) X 2(L)
BIOMET 3I, LLC
MSGIIM2
In Commercial Distribution

  • 00844868010500 ()

  • Diameter 3.4 mm
  • Length: 2 Millimeter


  • Surgical screwdriver, reusable
NAVIGATOR® CERTAIN® IMPLANT MOUNT, 3.4MM(D) X 1(L)
BIOMET 3I, LLC
MSGIIM1
In Commercial Distribution

  • 00844868010494 ()

  • Length: 1 Millimeter
  • Diameter 3.4 mm


  • Surgical screwdriver, reusable
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