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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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ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812389
In Commercial Distribution

  • 00841549103452 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812388
In Commercial Distribution

  • 00841549103445 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812387
In Commercial Distribution

  • 00841549103438 ()


  • Dental implant suprastructure, permanent, preformed
9.6F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLECT PORT W/AT SILICONE CATHETER W/5FSILICONE C Micro-Stick®INTRODUCER SE
Medical Components, Inc.
MIPP96AFS
Not in Commercial Distribution

  • 50884908148928 ()
  • 00884908148923 ()
MIPP96AFS

  • Vascular port/catheter
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-1450
In Commercial Distribution

  • 04540778177239 ()

  • Complex (Standard) 14inch 14mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-1450

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-1250
In Commercial Distribution

  • 04540778177222 ()

  • Complex (Medium Soft) 14inch 12mm x 50cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-1250

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-1040
In Commercial Distribution

  • 04540778177208 ()

  • Complex (Medium Soft) 14inch 10mm x 40cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-1040

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0940
In Commercial Distribution

  • 04540778177185 ()

  • Complex (Soft) 14inch 9mm x 40cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0940

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0840
In Commercial Distribution

  • 04540778177154 ()

  • Complex (Soft) 14inch 8mm x 40cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0840

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0730
In Commercial Distribution

  • 04540778177123 ()

  • Complex (Soft) 12inch 7mm x 30cm
  • Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter
392-0730

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
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