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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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OsteoBoost, 5 cc - 00816125023394

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-05P
In Commercial Distribution

  • 00816125023394 ()
OB-05P

  • Bone matrix implant, synthetic, non-antimicrobial

CC T11-RD1 (CD2-RD1) - 15099590542542

COULTER CLONE T11-RD1
Beckman Coulter, Inc.
6602868
In Commercial Distribution

  • 15099590542542 ()
6602868

  • Multiple CD cell marker IVD, antibody

CS/CC B4-RD1 - 15099590542375

CYTO-STAT/COULTER CLONE B4-RD1
Beckman Coulter, Inc.
6603846
In Commercial Distribution

  • 15099590542375 ()
6603846

  • Multiple CD cell marker IVD, antibody

CS/CC MsIgG2b-FITC - 15099590542320

CYTO-STAT/COULTER CLONE MsIgG2b-FITC
Beckman Coulter, Inc.
6603853
In Commercial Distribution

  • 15099590542320 ()
6603853

  • Multiple CD cell marker IVD, control

CC T1-RD1 (CD5-RD1) - 15099590542016

COULTER CLONE T1-RD1
Beckman Coulter, Inc.
6603020
In Commercial Distribution

  • 15099590542016 ()
6603020

  • Multiple CD cell marker IVD, antibody

CC Mo2-FITC (CD14-FITC) - 15099590541590

COULTER CLONE Mo2-FITC
Beckman Coulter, Inc.
6602507
In Commercial Distribution

  • 15099590541590 ()
6602507

  • Multiple CD cell marker IVD, antibody

CC B1-FITC (CD20-FITC) - 15099590540951

COULTER CLONE B1-FITC
Beckman Coulter, Inc.
6602381
In Commercial Distribution

  • 15099590540951 ()
6602381

  • Multiple CD cell marker IVD, antibody

CS/CC MY4-FITC - 15099590540944

CYTO-STAT/COULTER CLONE MY4-FITC
Beckman Coulter, Inc.
6604110
In Commercial Distribution

  • 15099590540944 ()
6604110

  • Multiple CD cell marker IVD, antibody

CS/CC MsIgG1-RD1 - 15099590540920

CYTO-STAT/COULTER CLONE MsIgG1-RD1
Beckman Coulter, Inc.
6604112
In Commercial Distribution

  • 15099590540920 ()
6604112

  • Multiple CD cell marker IVD, control

CS/CC Mo2-FITC - 15099590540913

CYTO-STAT/COULTER CLONE Mo2-FITC
Beckman Coulter, Inc.
6604114
In Commercial Distribution

  • 15099590540913 ()
6604114

  • Multiple CD cell marker IVD, antibody
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