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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MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
ZB-KP210
In Commercial Distribution

  • 00810007632216 ()
ZB-KP210

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
ZB-KP200
In Commercial Distribution

  • 00810007632209 ()
ZB-KP200

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES BUNDLE
Medcad
MC-KTP400-H
In Commercial Distribution

  • 00810007632193 ()
MC-KTP400-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
MC-KP100
In Commercial Distribution

  • 00810007632032 ()
MC-KP100

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
MC-KP110
In Commercial Distribution

  • 00810007632025 ()
MC-KP110

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
MC-KP200
In Commercial Distribution

  • 00810007632018 ()
MC-KP200

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
MC-KP210
In Commercial Distribution

  • 00810007632001 ()
MC-KP210

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES BUNDLE
Medcad
MC-KP400
In Commercial Distribution

  • 00810007631998 ()
MC-KP400

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES BUNDLE
Medcad
MC-KP300
In Commercial Distribution

  • 00810007631981 ()
MC-KP300

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES BUNDLE
Medcad
MC-KTP400
In Commercial Distribution

  • 00810007631967 ()
MC-KTP400

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES BUNDLE
Medcad
MC-KTP300-H
In Commercial Distribution

  • 00810007631950 ()
MC-KTP300-H

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES BUNDLE
Medcad
MC-KTP300
In Commercial Distribution

  • 00810007631943 ()
MC-KTP300

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE AND TITANIUM HYBRID GUIDES BUNDLE
Medcad
MC-KTP200-H
In Commercial Distribution

  • 00810007631936 ()
MC-KTP200-H

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE AND TITANIUM GUIDES BUNDLE
Medcad
MC-KTP200
In Commercial Distribution

  • 00810007631929 ()
MC-KTP200

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE AND TITANIUM HYBRID GUIDES BUNDLE
Medcad
MC-KTP100-H
In Commercial Distribution

  • 00810007631912 ()
MC-KTP100-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT W/ ACCUPLATE AND TITANIUM GUIDES BUNDLE
Medcad
MC-KTP100
In Commercial Distribution

  • 00810007631905 ()
MC-KTP100

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND GUIDES, DOUBLE JAW BUNDLE
Medcad
MC-KP021
In Commercial Distribution

  • 00810007631899 ()
MC-KP021

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES, DOUBLE JAW BUNDLE
Medcad
MC-KP020
In Commercial Distribution

  • 00810007631882 ()
MC-KP020

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND GUIDES, SINGLE JAW BUNDLE
Medcad
MC-KP011
In Commercial Distribution

  • 00810007631875 ()
MC-KP011

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES, SINGLE JAW BUNDLE
Medcad
MC-KP010
In Commercial Distribution

  • 00810007631868 ()
MC-KP010

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND GUIDES BUNDLE
Medcad
MC-KP001
In Commercial Distribution

  • 00810007631851 ()
MC-KP001

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES BUNDLE
Medcad
MC-KP000
In Commercial Distribution

  • 00810007631844 ()
MC-KP000

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, DOUBLE JAW
Medcad
MC-KTP020-H
In Commercial Distribution

  • 00810007631837 ()
MC-KTP020-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, DOUBLE JAW
Medcad
MC-KTP020
In Commercial Distribution

  • 00810007631820 ()
MC-KTP020

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES
Medcad
MC-KTP000
In Commercial Distribution

  • 00810007631813 ()
MC-KTP000

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
MC-KP210
Not in Commercial Distribution

  • 00810007631660 ()
MC-KP210

  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
MC-KP200
Not in Commercial Distribution

  • 00810007631653 ()
MC-KP200

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
MC-KP110
Not in Commercial Distribution

  • 00810007631523 ()
MC-KP110

  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
MC-KP100
Not in Commercial Distribution

  • 00810007631516 ()
MC-KP100

  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
No Description
BIOMET SPINE LLC
50-6594MP
In Commercial Distribution

  • 00880304948235 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 40MM HF SEAT ASSY
50-6594MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6593MP
In Commercial Distribution

  • 00880304948228 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 35MM HF SEAT ASSY
50-6593MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6592MP
In Commercial Distribution

  • 00880304948211 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 30MM HF SEAT ASSY
50-6592MP

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
50-6591MP
In Commercial Distribution

  • 00880304948204 ()

  • TI VARIABLE LOCKING SCREW 5.0 X 25MM HF SEAT ASSY
50-6591MP

  • Bone-screw internal spinal fixation system, non-sterile
Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
AIRLIFE
9446-910
In Commercial Distribution

9446-910

  • Injectate temperature probe
Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
AIRLIFE
9446-910
In Commercial Distribution

  • 10190752125612 ()
9446-910

  • Injectate temperature probe
Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
Carefusion Finland 320 Oy
9446-910
Not in Commercial Distribution

  • 10885403258374 ()
9446-910

  • Injectate temperature probe
LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761588 ()
70335-000210

  • Physiologic-monitoring defibrillation system
LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761571 ()
70335-000211

  • Physiologic-monitoring defibrillation system
HELENE CO SET BLK/DEPO_GLD CO/ ASTIN- Frame Material: TR-90 / Metal - Oval Office Wear /Gold Frame Clip On - Lens Technology: Base: DigiTec® Anti-Reflective Coating (Base) Clip: TriLenium® 7 Polarized lens- Sunglasses
Eagle Eyes
22017
In Commercial Distribution

  • 00810712013454 ()
22017

  • Tinted non-prescription spectacle lens
Wired Acquisition System cleared with the Xscribe/Q-Stress Stress System
MORTARA INSTRUMENT, INC.
9293-062-50
In Commercial Distribution

  • 00812345029697 ()


  • Electrocardiographic lead set, reusable
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