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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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restor3d Total Talus Replacement - 00840097509808

Total Talus, With Suture Hole, 95%
Restor3d, Inc.
1102-12
In Commercial Distribution

  • 00840097509808 ()


  • Custom-made hand/foot bone prosthesis

restor3d Total Talus Replacement - 00840097509792

Total Talus, With Suture Hole, 90%
Restor3d, Inc.
1102-11
In Commercial Distribution

  • 00840097509792 ()


  • Custom-made hand/foot bone prosthesis

NA - 03596010611529

6.5MM CANNULATED TAP WITH QUICK CONNECT
Smith & Nephew, Inc.
71177143
In Commercial Distribution

  • 03596010611529 ()
71177143

  • Bone tap, reusable

ELITE - 03596010607584

ELITE PASS LONG BITE WITH RATCHET
Smith & Nephew, Inc.
72201840
In Commercial Distribution

  • 03596010607584 ()
72201840

  • Suturing unit, reusable

LARGE CANNULATED SCREWS - 03596010601582

4.7MM HEXDRIVER SHAFT WITH QUICK CONNECT
Smith & Nephew, Inc.
71177158
In Commercial Distribution

  • 03596010601582 ()
71177158

  • Surgical screwdriver, reusable

ACUFEX - 03596010593719

MTO GRASPER WITH NOT TEETH 2.7MM
Smith & Nephew, Inc.
72201621
In Commercial Distribution

  • 03596010593719 ()
72201621

  • Rigid endoscopic grasping forceps, reusable

NA - 03596010591289

DRILL FLUTED 3.0MM WITH DEPTH STOP
Smith & Nephew, Inc.
72201198
In Commercial Distribution

  • 03596010591289 ()
72201198

  • Fluted surgical drill bit, reusable

NA - 03596010553171

WRIST ARTHROSCOPY ACCESSORY WITH WRIST PLATE
Smith & Nephew, Inc.
72200660
In Commercial Distribution

  • 03596010553171 ()
72200660

  • Arm procedure positioner, reusable

ACUMED - 10806378055560

4.0mm Easy Out with Trocar Tip
Acumed LLC
AP-67008
In Commercial Distribution

  • 10806378055560 ()


  • General internal orthopaedic fixation system implantation kit

ACUMED - 10806378046797

Straight Ball Spike with Impact Cap
Acumed LLC
80-1124
In Commercial Distribution

  • 10806378046797 ()


  • General internal orthopaedic fixation system implantation kit
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