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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 Connexus - 10889981055479

Accell Connexus, 2.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-025
In Commercial Distribution

  • M3860230000251 ()
  • 10889981055479 ()

  • 2.5cc
02-3000-025

  • Bone matrix implant, human-derived

Accell Connexus - 10889981055455

Accell Connexus, 0.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-3000-005
In Commercial Distribution

  • M3860230000051 ()
  • 10889981055455 ()

  • 0.5cc
02-3000-005

  • Bone matrix implant, human-derived

Accell Evo3 C Putty - 10889981055424

Accell Evo3c Putty, 2.5cc - demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Accell Evo3c is formulated into a putty form and is provided in a sterile, single use package
ISOTIS ORTHOBIOLOGICS, INC.
02-6000-025
In Commercial Distribution

  • M3860260000251 ()
  • 10889981055424 ()

  • 2.5cc
02-6000-025

  • Bone matrix implant, human-derived

Accell Evo3 Putty - 10889981055400

Accell Evo3 Putty,5 cc - 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.
02-5000-050
In Commercial Distribution

  • M3860250000501 ()
  • 10889981055400 ()

  • 5cc
02-5000-050

  • Bone matrix implant, human-derived

Accell Evo3 Putty - 10889981055394

Accell Evo3 Putty, 2.5cc - 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.
02-5000-025
In Commercial Distribution

  • M3860250000251 ()
  • 10889981055394 ()

  • 2.5cc
02-5000-025

  • Bone matrix implant, human-derived

GRAFTON PLUS™ DBM - 00643169965102

DBM T45005INT 5CC PASTE GRAFTON PLUS
MEDTRONIC SOFAMOR DANEK, INC.
T45005INT
In Commercial Distribution

  • 00643169965102 ()


  • Bone matrix implant, human-derived

GRAFTON PLUS® DBM - 00643169965096

DBM T45001INT 1CC PASTE GRAFTON PLUS
MEDTRONIC SOFAMOR DANEK, INC.
T45001INT
In Commercial Distribution

  • 00643169965096 ()

  • 1CC


  • Bone matrix implant, human-derived

GRAFTON® DBM - 00643169965089

DBM T44150INT 10CC GRAFTON ORTHOBLEND SM
MEDTRONIC SOFAMOR DANEK, INC.
T44150INT
In Commercial Distribution

  • 00643169965089 ()


  • Bone matrix implant, human-derived

GRAFTON® DBM - 00643169965065

DBM T44135INT 15CC GRAFTON ORTHOBLEND LG
MEDTRONIC SOFAMOR DANEK, INC.
T44135INT
In Commercial Distribution

  • 00643169965065 ()

  • 15cc


  • Bone matrix implant, human-derived

GRAFTON® DBM - 00643169965010

DBM T43204INT 0.25CC GRAFTON PUTTY SYRNG
MEDTRONIC SOFAMOR DANEK, INC.
T43204INT
In Commercial Distribution

  • 00643169965010 ()


  • Bone matrix implant, human-derived
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