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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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TruMatch - 05420060380129

TRUMATCH Orthognathics - Basic Mandibular Surgical Kit, without Planning
Materialise NV
SD980.012
In Commercial Distribution

  • 05420060380129 ()
SD980.012

  • Craniofacial fixation plate kit, non-bioabsorbable

TruMatch - 05420060380112

TRUMATCH Orthognathics - Basic Mandibular Surgical Kit
Materialise NV
SD980.011
In Commercial Distribution

  • 05420060380112 ()
SD980.011

  • Craniofacial fixation plate kit, non-bioabsorbable

TruMatch - 05420060380105

TRUMATCH Orthognathics - Full Mandibular Surgical Kit, without planning
Materialise NV
SD980.010
In Commercial Distribution

  • 05420060380105 ()
SD980.010

  • Craniofacial fixation plate kit, non-bioabsorbable

TruMatch - 05420060380075

TRUMATCH Orthognathics - Basic Maxillary Surgical Kit
Materialise NV
SD980.007
In Commercial Distribution

  • 05420060380075 ()
SD980.007

  • Craniofacial fixation plate kit, non-bioabsorbable

TruMatch - 05420060380068

TRUMATCH Orthognathics - Full Maxillary Surgical Kit, without planning
Materialise NV
SD980.006
In Commercial Distribution

  • 05420060380068 ()
SD980.006

  • Craniofacial fixation plate kit, non-bioabsorbable

Spirotome Bone - 05407005001240

The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 10G (4 mm) and length of 150 mm.
Bioncise
SS10BO
In Commercial Distribution

  • 05407005000243 ()
  • 05407005001240 ()
SS10BO

  • Soft-tissue biopsy needle, single-use

Spirotome Bone - 05407005001233

The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 08G (5mm) and length of 150 mm.
Bioncise
SS08BO
In Commercial Distribution

  • 05407005000236 ()
  • 05407005001233 ()
SS08BO

  • Soft-tissue biopsy needle, single-use

Jacoti Hearing Center Pro - 05407004250038

Jacoti Hearing Center Pro 1.X
Jacoti
Jacoti Hearing Center Pro 1.X
In Commercial Distribution

  • 05407004250038 ()


  • Tone audiometer, semi-automated

Handi-Move Slide - 05404016612588

Handi Slide padded mini
Handi-Move
3606 00000001
In Commercial Distribution

  • 05404016612588 ()


  • Patient transfer sliding mat

Handi-Move Slide - 05404016612571

Handi Slide padded maxi
Handi-Move
3605 00000001
In Commercial Distribution

  • 05404016612571 ()


  • Patient transfer sliding mat
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