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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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The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 12A-B
In Commercial Distribution

  • 05712821010629 ()
  • 05712821010667 ()
IO 12A-B

  • Dental implant suprastructure, temporary, preformed, reusable
Fiber Facing For #2 Mallet Pair
HU-FRIEDY MFG. CO., LLC
PTNFM2
Not in Commercial Distribution

  • 10889950127497 ()
  • 10889950087234 ()
PTNFM2

  • Surgical mallet
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
Baylis Médicale Cie Inc
PSZ-200-301
Not in Commercial Distribution

  • 00685447001904 ()


  • Surgical screwdriver, reusable
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
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