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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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AccuPlan System - 00810007630366

MANDIBLE RECONSTRUCTION, SURGICAL GUIDE
Medcad
MC-K011
In Commercial Distribution

  • 00810007630366 ()
MC-K011

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan System - 00810007630359

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT - REPORT
Medcad
MC-K010-R
In Commercial Distribution

  • 00810007630359 ()
MC-K010-R

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan System - 00810007630342

ORTHOGNATHIC, SURGICAL GUIDE
Medcad
MC-K004
In Commercial Distribution

  • 00810007630342 ()
MC-K004

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan System - 00810007630335

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT
Medcad
MC-K010
In Commercial Distribution

  • 00810007630335 ()
MC-K010

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan System - 00810007630328

ORTHOGNATHIC, 3D PRINTED DENTAL MODELS
Medcad
MC-K003
In Commercial Distribution

  • 00810007630328 ()
MC-K003

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan System - 00810007630311

ORTHOGNATHIC, FINAL SPLINT
Medcad
MC-K002
In Commercial Distribution

  • 00810007630311 ()
MC-K002

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan System - 00810007630304

ORTHOGNATHIC, INTERMEDIATE SPLINT
Medcad
MC-K001
In Commercial Distribution

  • 00810007630304 ()
MC-K001

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan System - 00810007630298

ORTHOGNATHIC, SURGICAL PLANNING KIT
Medcad
MC-K000
In Commercial Distribution

  • 00810007630298 ()
MC-K000

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

X-Guide - 00817421021435

BONE SCREW, EDX - 3.2Ø x 16mm
XNAV TECHNOLOGIES LLC
P010308
In Commercial Distribution

  • 00817421021442 ()
  • 00817421021435 ()
  • 00817421022739 ()
P010308

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable

X-Guide - 00817421021411

BONE SCREW, EDX - 3.2Ø x 8mm
XNAV TECHNOLOGIES LLC
P010307
In Commercial Distribution

  • 00817421021428 ()
  • 00817421021411 ()
  • 00817421022722 ()
P010307

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
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