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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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The threaded rod is used to connect and support rings in the construct. The rod is made from stainless steel.
Ascension Orthopedics, Inc.
12224243
In Commercial Distribution

  • 10381780125372 ()

  • 115 mm L
12224243

  • External orthopaedic fixation system, reusable
The threaded rod is used to connect and support rings in the construct. The rod is made from stainless steel.
Ascension Orthopedics, Inc.
12224242
In Commercial Distribution

  • 10381780125365 ()

  • 85 mm L
12224242

  • External orthopaedic fixation system, reusable
The threaded rod is used to connect and support rings in the construct. The rod is made from stainless steel.
Ascension Orthopedics, Inc.
12224241
In Commercial Distribution

  • 10381780125358 ()

  • 60 mm L
12224241

  • External orthopaedic fixation system, reusable
The threaded rod is used to connect and support rings in the construct. The rod is made from stainless steel.
Ascension Orthopedics, Inc.
12224240
In Commercial Distribution

  • 10381780125341 ()

  • 20 mm L
12224240

  • External orthopaedic fixation system, reusable
EchoMark LP is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
SONAVEX, INC.
2000
In Commercial Distribution

  • B53620001 ()

  • Small


  • Radiological image marker, implantable
Accell TBM, 5x5 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-550
In Commercial Distribution

  • M3860240005501 ()
  • 10889981055653 ()

  • 5cmx5cm
02-4000-550

  • Bone matrix implant, human-derived
Accell TBM, 5x2 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-520
In Commercial Distribution

  • M3860240005201 ()
  • 10889981055646 ()

  • 5cmX2cm
02-4000-520

  • Bone matrix implant, human-derived
Trel-XPress 100, 2.5cc is made using demineralized human bone mixed with poloxamer reverse phase medium. Trel-XPress 100 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES125
In Commercial Distribution

  • M386XPRES1251 ()
  • 10381780112532 ()

  • 2.5cc
XPRES125

  • Bone matrix implant, human-derived
Trel-XPress 100, 5cc is made using demineralized human bone mixed with poloxamer reverse phase medium. Trel-XPress 100 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES105
In Commercial Distribution

  • M386XPRES1051 ()
  • 10381780112525 ()

  • 5cc
XPRES105

  • Bone matrix implant, human-derived
Trel-XPress 100, 10cc is made using demineralized human bone mixed with poloxamer reverse phase medium. Trel-XPress 100 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES110
In Commercial Distribution

  • M386XPRES1101 ()
  • 10381780112518 ()

  • 10cc
XPRES110

  • Bone matrix implant, human-derived
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