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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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Tobra Full Dose Antibiotic Bone Cement, 10 pack catalog number is 6197-9-010
Howmedica Osteonics Corp.
6197-9-001
In Commercial Distribution

  • 37613327128421 ()
  • 07613327128420 ()
  • 57613327128425 ()

  • Weight: 41.0 Gram
  • Total Volume: 20.0 Milliliter
6197-9-001

  • Orthopaedic cement, antimicrobial
SpeedSet Full Dose Antibiotic Bone Cement, 10 pack catalog number is 6192-1-010
Howmedica Osteonics Corp.
6192-1-001
In Commercial Distribution

  • 37613327128452 ()
  • 07613327128451 ()
  • 57613327128456 ()

  • Weight: 40.0 Gram
  • Total Volume: 20.0 Milliliter
6192-1-001

  • Orthopaedic cement, antimicrobial
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, 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.
56300050
In Commercial Distribution

  • M386563000501 ()
  • 10889981055813 ()

  • 5cc
56300050

  • 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
OsteoSurge100, 1cc - 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.
56300010
In Commercial Distribution

  • M386563000101 ()
  • 10889981055790 ()

  • 1cc
56300010

  • Bone matrix implant, human-derived
MOLLI Introducer and MOLLI Marker (12 cm, 14GA) For use with the MOLLI System Note, the Introducer is MR Unsafe, however, the implantable Marker is MR conditional.
Molli Surgical Inc
MS-00009
In Commercial Distribution

  • 00850024195080 ()
  • 00850024195134 ()
MM1012

  • Radiological image marker, implantable
The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet acellular collagen.
ADMEDUS REGEN PTY LTD
UC0404N
In Commercial Distribution

  • 09348992000143 ()

  • Width: 4 Centimeter
  • Length: 4 Centimeter
C0404

  • Cardiovascular patch, animal-derived
The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into the carpal bones with a cemented central peg and two titanium screws.
Ascension Orthopedics, Inc.
262402
In Commercial Distribution

  • M2482624021 ()
  • 10381780066040 ()

  • 42.8 mm L x 21.25 mm H; Size Large +2
262402

  • Total wrist prosthesis
The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into the carpal bones with a cemented central peg and two titanium screws.
Ascension Orthopedics, Inc.
262401
In Commercial Distribution

  • M2482624011 ()
  • 10381780066033 ()

  • 42.8 mm L x 18.75 mm H; Size Large +1
262401

  • Total wrist prosthesis
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