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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INSTRUMENT 9680927 SOLID T30 QUICK ECT
MEDTRONIC SOFAMOR DANEK, INC.
9680927
In Commercial Distribution

  • 00681490885638 ()


  • Orthopaedic implant driver
INSTRUMENT 8951607 REAMER PLUG 16MM
MEDTRONIC SOFAMOR DANEK, INC.
8951607
In Commercial Distribution

  • 00681490847100 ()


  • Surgical screwdriver, reusable
INSTRUMENT 8950005 SGL BARRL OS DRVR CAP
MEDTRONIC SOFAMOR DANEK, INC.
8950005
In Commercial Distribution

  • 00681490846851 ()


  • Orthopaedic implant driver
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
No Description
Biomet Orthopedics, LLC
X31-400061
In Commercial Distribution

  • 00880304183667 ()
X31-400061

  • Surgical mallet
No Description
Biomet Orthopedics, LLC
424417
In Commercial Distribution

  • 00880304009424 ()
424417

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
424493
In Commercial Distribution

  • 00880304009417 ()
424493

  • Surgical screwdriver, reusable
4mm Driver, Tri-Flat, Small Stature
Seaspine Orthopedics Corporation
97-6385
In Commercial Distribution

  • 10889981153106 ()

  • 4mm
97-6385

  • Orthopaedic inorganic implant inserter/extractor, reusable
Locking Driver Shaft, Tri-Flat, Small Stature
Seaspine Orthopedics Corporation
97-6300
In Commercial Distribution

  • 10889981153007 ()
97-6300

  • Orthopaedic inorganic implant inserter/extractor, reusable
Navigation Coral MIS Screwdriver, 1/4 Square
Seaspine Orthopedics Corporation
77-0024
In Commercial Distribution

  • 10889981150075 ()
77-0024

  • Surgical screwdriver, reusable
Navigation Coral Reduction Screwdriver, 1/4 Square
Seaspine Orthopedics Corporation
77-0022
In Commercial Distribution

  • 10889981150051 ()
77-0022

  • Surgical screwdriver, reusable
No Description
Baylis Médicale Cie Inc
PSZ-200-301
Not in Commercial Distribution

  • 00685447001904 ()


  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
111301500
In Commercial Distribution

  • 06902139112439 ()
111301500

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
111301000
In Commercial Distribution

  • 06902139112408 ()
111301000

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
111300600
In Commercial Distribution

  • 06902139112392 ()
111300600

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
111226400
In Commercial Distribution

  • 06902139112347 ()
111226400

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
111226200
In Commercial Distribution

  • 06902139112330 ()
111226200

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
111225400
In Commercial Distribution

  • 06902139112255 ()
111225400

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
111225200
In Commercial Distribution

  • 06902139112248 ()
111225200

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
111193200
In Commercial Distribution

  • 06902139112019 ()
111193200

  • Surgical mallet
No Description
Double Medical Technology Inc.
110304100
In Commercial Distribution

  • 06902139111814 ()
110304100

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
110303600
In Commercial Distribution

  • 06902139111760 ()
110303600

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
110302400
In Commercial Distribution

  • 06902139111654 ()
110302400

  • Surgical mallet
No Description
Double Medical Technology Inc.
110301200
In Commercial Distribution

  • 06902139111531 ()
110301200

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
110301100
In Commercial Distribution

  • 06902139111524 ()
110301100

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
110211100
In Commercial Distribution

  • 06902139111401 ()
110211100

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
110211000
In Commercial Distribution

  • 06902139111395 ()
110211000

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
110201200
In Commercial Distribution

  • 06902139111319 ()
110201200

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
110201100
In Commercial Distribution

  • 06902139111302 ()
110201100

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
110190800
In Commercial Distribution

  • 06902139111159 ()
110190800

  • Surgical screwdriver, reusable
No Description
Double Medical Technology Inc.
110071600
In Commercial Distribution

  • 06902139110947 ()
110071600

  • Surgical screwdriver, reusable
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