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 8230918 3.5MM UNV SCRW HX DR
MEDTRONIC SOFAMOR DANEK, INC.
8230918
In Commercial Distribution

  • 00673978781259 ()


  • Surgical screwdriver, reusable
INSTRUMENT 8230912 BONE SCRW HX DR LNG
MEDTRONIC SOFAMOR DANEK, INC.
8230912
In Commercial Distribution

  • 00673978781204 ()


  • Orthopaedic implant driver
INSTRUMENT 8230911 3.5MM CPTV TWST HX DR
MEDTRONIC SOFAMOR DANEK, INC.
8230911
In Commercial Distribution

  • 00673978781198 ()


  • Orthopaedic implant driver
INSULATD MULTI-AXL SCRW HXDRVR
MEDTRONIC SOFAMOR DANEK, INC.
X0899030
In Commercial Distribution

  • 00673978997346 ()


  • Orthopaedic implant driver
ATLANTIS PLATE PIN DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0799004
In Commercial Distribution

  • 00673978996684 ()


  • Orthopaedic implant driver
TSRH-3D CANN SCREWDRIVER SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0400011
In Commercial Distribution

  • 00673978996493 ()


  • Orthopaedic implant driver
M10 MAS SCREWDRIVER SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0400008
In Commercial Distribution

  • 00673978996462 ()


  • Orthopaedic implant driver
CANULATED SACRAL SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0200029
In Commercial Distribution

  • 00673978995182 ()


  • Surgical screwdriver, reusable
INSTRUMENT 9680050 M10 MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
9680050
In Commercial Distribution

  • 00673978963402 ()


  • Surgical screwdriver, reusable
SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0100055
In Commercial Distribution

  • 00673978994895 ()


  • Surgical screwdriver, reusable
INSTRUMENT 907-404 TANGENT MALLET
MEDTRONIC SOFAMOR DANEK, INC.
907-404
In Commercial Distribution

  • 00673978958095 ()


  • Surgical mallet
Condyle Position Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469285 ()
CGPTI

  • Custom-made orthopaedic/craniofacial surgical guide
Guide anchor screws with dental support Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469278 ()
GASDSTI

  • Custom-made orthopaedic/craniofacial surgical guide
BSSO Surgical Guide with Dental Support - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469261 ()
GCSDTI

  • Custom-made orthopaedic/craniofacial surgical guide
BSSO Surgical Guide - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469230 ()
GCSTI

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthognathic Surgical Splint - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469223 ()
FPCOBC

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthognathic Surgical Splint - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469216 ()
FPCOTI

  • Custom-made orthopaedic/craniofacial surgical guide
Screw metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801680 ()
Q-SPTS

  • Custom-made orthopaedic/craniofacial surgical guide
Slot metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801673 ()
Q-SPCS

  • Custom-made orthopaedic/craniofacial surgical guide
Drill metal sleeve
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801666 ()
Q-SPBS

  • Custom-made orthopaedic/craniofacial surgical guide
Genioplasty Surgical Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801659 ()
GCGTI

  • Custom-made orthopaedic/craniofacial surgical guide
Genioplasty Surgical Guide with dental support - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801642 ()
GCGSDTI

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801635 ()
GCLTI

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide with dental support - TI
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801628 ()
GCLSDTI

  • Custom-made orthopaedic/craniofacial surgical guide
Genioplasty Surgical Guide with Splint - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801611 ()
GCGFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Genioplasty Surgical Guide - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860010801604 ()
GCGBC

  • Custom-made orthopaedic/craniofacial surgical guide
Patient-specific, Maxillofacial Anatomical Model, Digital
3D LIFEPRINTS UK LTD
CMFDAM
Not in Commercial Distribution

  • 00860009815735 ()


  • Custom-made organ/bone anatomy model
Patient-specific, Maxillofacial Surgical Guide
3D LIFEPRINTS UK LTD
CMFSG
In Commercial Distribution

  • 00860009815728 ()


  • Custom-made orthopaedic/craniofacial surgical guide
Patient-specific, Maxillofacial Anatomical Model, For End-user Sterilization
3D LIFEPRINTS UK LTD
CMFAMFEUS
In Commercial Distribution

  • 00860009815711 ()


  • Custom-made organ/bone anatomy model
Patient-specific, Maxillofacial Anatomical Model, Non-sterile
3D LIFEPRINTS UK LTD
CMFAMNS
In Commercial Distribution

  • 00860009815704 ()


  • Custom-made organ/bone anatomy model
No Description
General Vibronics, LLC
GVM2
In Commercial Distribution

  • 00860013508616 ()


  • Medium-wave diathermy treatment system generator
Maxilla Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759460 ()
GCMAXTI

  • Custom-made orthopaedic/craniofacial surgical guide
Mandible Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759453 ()
GCMANTI

  • Custom-made orthopaedic/craniofacial surgical guide
Fibula cutting guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759446 ()
GCPTI

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759422 ()
FPCOD

  • Custom-made orthopaedic/craniofacial surgical guide
Interm Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759415 ()
FICOD

  • Custom-made orthopaedic/craniofacial surgical guide
Final Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759408 ()
FFCOD

  • Custom-made orthopaedic/craniofacial surgical guide
The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization.
Elos Medtech Pinol A/S
C31711
In Commercial Distribution

  • 05712821008398 ()
  • 05712821009487 ()
C31711

  • Surgical torque wrench adaptor
A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Elos Medtech Pinol A/S
C20895
In Commercial Distribution

  • 05712821007599 ()
  • 05712821009470 ()


  • Surgical torque wrench adaptor
The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Elos Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
C8147
In Commercial Distribution

  • 05712821007544 ()
  • 05712821007537 ()
LLMTP

  • Dental torque wrench
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