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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/AccuPlate - 00810007631660

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

AccuPlan/AccuPlate - 00810007631653

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

AccuPlan/AccuPlate - 00810007631523

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

AccuPlan/AccuPlate - 00810007631516

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

AccuPlan/AccuPlate - 00810007631318

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
ZB-KP200
Not in Commercial Distribution

  • 00810007631318 ()
ZB-KP200

  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan/AccuPlate - 00810007631301

MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
ZB-KP210
Not in Commercial Distribution

  • 00810007631301 ()
ZB-KP210

  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan/AccuPlate - 00810007631172

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE, NO GUIDES
Medcad
ZB-KP110
Not in Commercial Distribution

  • 00810007631172 ()
ZB-KP110

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan/AccuPlate - 00810007631165

MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE
Medcad
ZB-KP100
Not in Commercial Distribution

  • 00810007631165 ()
ZB-KP100

  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Lap Port Closure Device Kit with10/12mm and 15mm Guides - B354OSLPCDK15

Lap Port Closure Device Kit with10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDK15
In Commercial Distribution

  • B354OSLPCDK15 ()
OSLPCDK15

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Cell morphology analyser IVD, automated/semi-automated

3 Ring Suture Passer Kit with 10/12mm and 15mm Guides - B354OS3CDK15

3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B354OS3CDK15 ()
OS3CDK15

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Cell morphology analyser IVD, automated/semi-automated
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