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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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I3 IMPLANT LLC
i3CCSA
In Commercial Distribution

  • 00850008541797 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2508SX
In Commercial Distribution

  • 00813909013206 ()

  • 8.0cc
NB2508SX

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2515
In Commercial Distribution

  • 00813909011073 ()

  • 15.0cc
NB2515

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2510
In Commercial Distribution

  • 00813909011066 ()

  • 10.0cc
NB2510

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2508
In Commercial Distribution

  • 00813909011059 ()

  • 8.0cc
NB2508

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2505
In Commercial Distribution

  • 00813909011042 ()

  • 5.0cc
NB2505

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2502
In Commercial Distribution

  • 00813909011035 ()

  • 2.6cc
NB2502

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2508TM
In Commercial Distribution

  • 00813909013039 ()

  • 8.0cc
NB2508TM

  • Bone matrix implant, synthetic, non-antimicrobial
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB2508FO
In Commercial Distribution

  • 00813909012940 ()

  • 8.0cc
NB2508FO

  • Bone matrix implant, synthetic, non-antimicrobial
OsteoBoost is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, OsteoBoost resorbs and is later replaced by natural bone. It provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. OsteoBoost is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
OB-10P
In Commercial Distribution

  • 00816125023400 ()
OB-10P

  • Bone matrix implant, synthetic, non-antimicrobial
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