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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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HANAROSTENT® Esophagus Asymmetric (CCC) - 08806367044761

Full Covered metallic esophagus stent
M.I.Tech Co., Ltd.
ECN24140-Z070
In Commercial Distribution

  • 08806367044761 ()

  • 700 mm Delivery system
  • Stent Diameter: 24 Millimeter
  • Stent Length: 140 Millimeter


  • Polymer-metal oesophageal stent

HANAROSTENT® Esophagus Asymmetric (CCC) - 08806367044754

Full Covered metallic esophagus stent
M.I.Tech Co., Ltd.
ECN24130-Z070
In Commercial Distribution

  • 08806367044754 ()

  • 700 mm Delivery system
  • Stent Diameter: 24 Millimeter
  • Stent Length: 130 Millimeter


  • Polymer-metal oesophageal stent

Gibralt® - M711050002640240

Posterior Cervical Screw Assembly, Smooth, 4.0mm X 24mm, Ti 6Al 4V (ELI)
Innovasis, Inc.
05-000-26-4024
In Commercial Distribution

  • M711050002640240 ()

  • Length: 24 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

Gibralt® - M711050002635240

Posterior Cervical Screw Assembly, Smooth, 3.5mm X 24mmTi 6Al 4V (ELI)
Innovasis, Inc.
05-000-26-3524
In Commercial Distribution

  • M711050002635240 ()

  • Length: 24 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Gibralt® - M711050002040240

Posterior Cervical Screw Assembly, 4.0mm X 24mm, Ti 6Al 4V (ELI)
Innovasis, Inc.
05-000-20-4024
In Commercial Distribution

  • M711050002040240 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 24 Millimeter


  • Spinal bone screw, non-bioabsorbable

Gibralt® - M711050002035240

Posterior Cervical Screw Assembly, 3.5mm X 24mm, Ti 6Al 4V (ELI)
Innovasis, Inc.
05-000-20-3524
In Commercial Distribution

  • M711050002035240 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 24 Millimeter


  • Spinal bone screw, non-bioabsorbable

FixxSure® - M71160240

No Description
Innovasis, Inc.
6024
In Commercial Distribution

  • M71160240 ()

  • Length: 24 Millimeter
  • Lumen/Inner Diameter: 6.0 Millimeter
6024

  • Bone-screw internal spinal fixation system connector

FixxSure® - M71155240

No Description
Innovasis, Inc.
5524
In Commercial Distribution

  • M71155240 ()

  • Length: 24 Millimeter
  • Lumen/Inner Diameter: 5.5 Millimeter
5524

  • Bone-screw internal spinal fixation system connector

Butrex Buttress Plating System - M697X02300231

4.5mm Fixed Screw, 24mm
Xtant Medical Holdings, Inc.
X023-0023
Not in Commercial Distribution

  • M697X02300231 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 24 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Butrex Buttress Plating System - M697X02300131

4.3mm Fixed Screw, 24mm
Xtant Medical Holdings, Inc.
X023-0013
Not in Commercial Distribution

  • M697X02300131 ()

  • Outer Diameter: 4.3 Millimeter
  • Length: 24 Millimeter


  • Spinal fixation plate, non-bioabsorbable
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