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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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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
The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
TAEWOONGMEDICAL.CO.,LTD
OCT1908
In Commercial Distribution

  • 08809909406423 ()
OCT1908

  • Endoscopic electrosurgical electrode, monopolar, single-use
The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
TAEWOONGMEDICAL.CO.,LTD
OCT1907
In Commercial Distribution

  • 08809909406416 ()
OCT1907

  • Endoscopic electrosurgical electrode, monopolar, single-use
The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
TAEWOONGMEDICAL.CO.,LTD
OCT1906
In Commercial Distribution

  • 08809909406409 ()
OCT1906

  • Endoscopic electrosurgical electrode, monopolar, single-use
The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SM-200-003
In Commercial Distribution

  • B815SM2000030 ()
SM-200-003

  • Haemodialysis blood tubing set, single-use
The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SA-400-00
In Commercial Distribution

  • B815SA400000 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use
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