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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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Mallet used for cervical inter-vertebral body spacer placement
CALVARY SPINE, LLC
Mallet
In Commercial Distribution

  • B114214000 ()
214-00

  • Surgical mallet
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 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
4mm Hex Driver Long
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0076
In Commercial Distribution

  • B432360CAS00760 ()


  • Robotic surgical navigation system application software
CAS Flex Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0068
In Commercial Distribution

  • B432360CAS00680 ()


  • Robotic surgical navigation system application software
No Description
Modern Surgical Instruments LLC
81-0106
In Commercial Distribution

  • B4198101060 ()


  • Surgical screwdriver, reusable
No Description
Modern Surgical Instruments LLC
27.10.70
In Commercial Distribution

  • B4192710700 ()


  • Surgical mallet
AO Self Retaining Driver
FLOSPINE LLC
Panama™
In Commercial Distribution

  • B1830870000210 ()
08-7000-021

  • Surgical screwdriver, reusable
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