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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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Visualase Anchor Bolt Driver Guide for Autoguide (1) Anchor Bolt Driver Guide for Stealth Autoguide
FHC, INC.
9736543-00914
In Commercial Distribution

  • 00873263009147 ()
9736543

  • Neurological stereotactic surgery system
Visualase Anchor Bolt Driver Guide for ROSA ONE (1) Anchor Bolt Driver Guide for ROSA ONE Brain
FHC, INC.
9736542-00913
In Commercial Distribution

  • 00873263009130 ()
9736542

  • Neurological stereotactic surgery system
Visualase Anchor Bolt Guide for Leksell (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame
FHC, INC.
9736541-00912
In Commercial Distribution

  • 00873263009123 ()
9736541

  • Neurological stereotactic surgery system
Visualase Anchor Bolt Driver Guide for CRW (1) Anchor Bolt Driver Guide for CRW Stereotactic System
FHC, INC.
9736540-00911
In Commercial Distribution

  • 00873263009116 ()
9736540

  • Neurological stereotactic surgery system
Visualase Anchor Bolt Driver (1) Anchor Bolt Driver
FHC, INC.
9736539-00910
In Commercial Distribution

  • 00873263009109 ()
9736539

  • Neurological stereotactic surgery system
Visualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Autoguide (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame (1) Anchor Bolt Driver Guide for ROSA ONE Brain (1) Anchor Bolt Driver Guide for CRW Stereotactic System
FHC, INC.
9736537-00908
In Commercial Distribution

  • 00873263009086 ()
9736537

  • Neurological stereotactic surgery system
microTargeting WayPoint Implantation Kit, Reusable Components Contains: Sterilization Case Combination Bit WayPoint Driver 4mm
FHC, INC.
66-WP-RU-00708
In Commercial Distribution

  • 00873263007082 ()
66-WP-RU

  • Neurological stereotactic surgery system
microTargeting WayPoint Implantation Kit, Reusable Components Contains: Sterilization Case Combination Bit WayPoint Driver 4mm
FHC, INC.
66-WP-RU-00533
Not in Commercial Distribution

  • 00873263005354 ()
  • 00873263005330 ()
66-WP-RU

  • Neurological stereotactic surgery system
No Description
Biomet Orthopedics, LLC
424495
In Commercial Distribution

  • 00880304009394 ()
424495

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
31-476946
In Commercial Distribution

  • 00880304008984 ()
31-476946

  • Orthopaedic implant driver
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