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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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4CIS® Marlin Rasp L - Lollipop
ALPHANOX CO.,LTD.
5901-0169
In Commercial Distribution

  • 08806373583520 ()
5901-0169

  • External spinal fixation system
4CIS® Marlin Bone Graft Handle
ALPHANOX CO.,LTD.
5901-0134
In Commercial Distribution

  • 08806373583186 ()
5901-0134

  • External spinal fixation system
Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Driver Handle Extractor
Shoulder Innovations, Inc.
RSA Handle Extractor
In Commercial Distribution

  • B1132R2HE000020 ()
2R2HE00002

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations Inset Reverse Total Shoulder - RSA T20 Driver
Shoulder Innovations, Inc.
RSA T20 Driver
In Commercial Distribution

  • B1132R2GT400200 ()
2R2GT40020

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations Inset Reverse Total Shoulder - RSA T15 Driver
Shoulder Innovations, Inc.
RSA T15 Driver
In Commercial Distribution

  • B1132R2GT400150 ()
2R2GT40015

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Driver Handle
Shoulder Innovations, Inc.
RSA Screw Driver Handle
In Commercial Distribution

  • B1132R2GT200000 ()
2R2GT20000

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations Inset Reverse Total Shoulder - RSA Set Screw Driver
Shoulder Innovations, Inc.
RSA Set Screw Driver
In Commercial Distribution

  • B1132R2GT100000 ()
2R2GT10000

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
BIOMET MICROFIXATION, INC
SP-2531
In Commercial Distribution

  • 00888233025430 ()
SP-2531

  • Craniofacial fixation plate, bioabsorbable
No Description
BIOMET MICROFIXATION, INC
SP-1966
In Commercial Distribution

  • 00888233025423 ()
SP-1966

  • Craniofacial fixation plate, bioabsorbable
No Description
BIOMET MICROFIXATION, INC
SP-1957
In Commercial Distribution

  • 00888233025416 ()
SP-1957

  • Craniofacial fixation plate, bioabsorbable
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