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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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Universal Liquid
KURARAY NORITAKE DENTAL INC.
#054-KA
In Commercial Distribution

  • EKUR000054KA1 ()


  • Dentine bonding agent/set
Catalyst Liquid
KURARAY NORITAKE DENTAL INC.
#053-KA
In Commercial Distribution

  • EKUR000053KA1 ()


  • Dentine bonding agent/set
TREPHINE SET FOR AUGMENTATION 3D ONE STEP AUGMENTATION KIT ACC. DR. GIESENHAGEN >> NEW COMPOSITION
Helmut Zepf Medizintechnik GmbH
47.500.31
In Commercial Distribution

  • EZPF47500310 ()
47.500.31

  • Periosteal elevator, reusable
Integra® Jarit® New Orleans Lens Loop, 5-1/2", 5mm x 10mm Loop
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
350420
In Commercial Distribution

  • M2743504201 ()
  • 10381780189671 ()

  • 5-1/2"
  • Width: 5 Millimeter
  • Length: 10 Millimeter
350-420

  • Lens loop, reusable
OsteoSurge300c Putty, 5cc - demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. OsteoSurge300c is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
56510050
In Commercial Distribution

  • M386565100501 ()
  • 10889981055875 ()

  • 5cc
56510050

  • Bone matrix implant, human-derived
OsteoSurge300 Putty, 10cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. OsteoSurge300 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
56500100
In Commercial Distribution

  • M386565001001 ()
  • 10889981055851 ()

  • 10cc
56500100

  • Bone matrix implant, human-derived
OsteoSurge100, 10cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
56300100
In Commercial Distribution

  • M386563001001 ()
  • 10889981055820 ()

  • 10cc
56300100

  • Bone matrix implant, human-derived
OsteoSurge100, 2.5cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
56300025
In Commercial Distribution

  • M386563000251 ()
  • 10889981055806 ()

  • 2.5cc
56300025

  • Bone matrix implant, human-derived
OsteoSparx C Paste, 8cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
56220080
In Commercial Distribution

  • M386562200801 ()
  • 10889981055769 ()

  • 8cc
56220080

  • Bone matrix implant, human-derived
OsteoSparx C Paste, 1cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
56220010
In Commercial Distribution

  • M386562200101 ()
  • 10889981055745 ()

  • 1cc
56220010

  • Bone matrix implant, human-derived
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