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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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OsteoBallast - 10889981149369

OsteoBallast, 85x11mm
ISOTIS ORTHOBIOLOGICS, INC.
56800115
In Commercial Distribution

  • 10889981149369 ()

  • 85x11mm
56800115

  • Bone matrix implant, human-derived

OsteoBallast - 10889981149352

OsteoBallast, 45x17.5mm
ISOTIS ORTHOBIOLOGICS, INC.
56800095
In Commercial Distribution

  • 10889981149352 ()

  • 45x17.5mm
56800095

  • Bone matrix implant, human-derived

OsteoBallast - 10889981149345

OsteoBallast, 45x11mm
ISOTIS ORTHOBIOLOGICS, INC.
56800060
In Commercial Distribution

  • 10889981149345 ()

  • 45x11mm
56800060

  • Bone matrix implant, human-derived

Ballast - 10889981149338

Ballast, 85x17.5mm
ISOTIS ORTHOBIOLOGICS, INC.
02-8000-180
In Commercial Distribution

  • 10889981149338 ()

  • 85x17.5mm
02-8000-180

  • Bone matrix implant, human-derived

Ballast - 10889981149321

Ballast, 85x11mm
ISOTIS ORTHOBIOLOGICS, INC.
02-8000-115
In Commercial Distribution

  • 10889981149321 ()

  • 85x11mm
02-8000-115

  • Bone matrix implant, human-derived

Ballast - 10889981149314

Ballast, 45x17.5mm
ISOTIS ORTHOBIOLOGICS, INC.
02-8000-095
In Commercial Distribution

  • 10889981149314 ()

  • 45x17.5mm
02-8000-095

  • Bone matrix implant, human-derived

Ballast - 10889981149307

Ballast, 45x11mm
ISOTIS ORTHOBIOLOGICS, INC.
02-8000-060
In Commercial Distribution

  • 10889981149307 ()

  • 45x11mm
02-8000-060

  • Bone matrix implant, human-derived

OsteoSurge 300 Putty - 10889981129729

OsteoSurge 300 Putty, 1cc -  demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.
ISOTIS ORTHOBIOLOGICS, INC.
56500010
In Commercial Distribution

  • 10889981129729 ()

  • 1cc
56500010

  • Bone matrix implant, human-derived

Accell Evo3 Putty - 10889981129712

Accell Evo3 Putty, 1cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.
Seaspine Orthopedics Corporation
02-5000-010
In Commercial Distribution

  • 10889981129712 ()

  • 1cc
02-5000-010

  • Bone matrix implant, human-derived

RTI Allograft Paste - 00854095006993

Allograft Strip IC 90mm
Rti Surgical, Inc.
803190
In Commercial Distribution

  • 00854095006993 ()


  • Bone matrix implant, human-derived
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