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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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Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single patient use. The kit contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together, the resultant paste is to be injected or digitally packed into open bone/gap to cure insitu. The biodegradable, radiopaque mixture is resorbed in approximately 30-60 days when used in accordance with the device labelling. Stimulan® is manufactured from synthetic implant grade calcium sulfate dihydrate (CaS04, 2H20) that resporbs and is replaced with bone during the healing process. Also as the bone void filler is biodegradable and biocompatible; it may be used at an infected site.
BIOCOMPOSITES LTD
640-005
In Commercial Distribution


  • 5cc
640-005

  • Synthetic bone graft
STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site.
BIOCOMPOSITES LTD
620-020
In Commercial Distribution


  • 20CC
620-020

  • Synthetic bone graft
STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site.
BIOCOMPOSITES LTD
620-010
In Commercial Distribution


  • 10cc
620-010

  • Synthetic bone graft
STIMULAN® Rapid Cure provided sterile for single patient use. STIMULAN® Rapid Cure contains calcium sulfate powder and mixing solution in pre-measured quantities so that when mixed together in a sterile mixing bowl, the resultant paste is to be digitally packed into open bone void/gap to set in situ or placed into the mould provided, the mixture sets to form beads. The biodegradable, radiopaque beads are resorbed in approximately 30 – 60 days when used in accordance with the device labelling. STIMULAN® Rapid Cure is manufactured from synthetic implant grade calcium sulfate dihydrate (CaSO4.2H2O) that resorbs and is replaced with bone during the healing process. Also, as the bone void filler beads are biodegradable and biocompatible, they may be used at an infected site.
BIOCOMPOSITES LTD
620-005
In Commercial Distribution


  • 5cc
620-005

  • Synthetic bone graft
geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe.When injected the mixture sets to form geneX®; a hard but resorbable matrix.
BIOCOMPOSITES LTD
980-005
In Commercial Distribution


  • 5cc
980-005

  • Synthetic bone graft
geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe.When injected the mixture sets to form geneX®; a hard but resorbable matrix.
BIOCOMPOSITES LTD
980-002
In Commercial Distribution


  • 2.5cc
980-002

  • Synthetic bone graft
The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok° Screw provides an interference fixation during femoral and/or tibial fixation in ACL reconstruction that resorbs and is replaced with bone during the healing process. Bilok® Screws are biodegradable and biocompatible.
BIOCOMPOSITES LTD
160-135T
In Commercial Distribution


  • Width: 10 Millimeter
  • Length: 35 Millimeter
160-135T

  • Bioabsorbable orthopaedic bone screw
The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok° Screw provides an interference fixation during femoral and/or tibial fixation in ACL reconstruction that resorbs and is replaced with bone during the healing process. Bilok® Screws are biodegradable and biocompatible.
BIOCOMPOSITES LTD
160-130T
In Commercial Distribution


  • Width: 10 Millimeter
  • Length: 30 Millimeter
160-130T

  • Bioabsorbable orthopaedic bone screw
The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok° Screw provides an interference fixation during femoral and/or tibial fixation in ACL reconstruction that resorbs and is replaced with bone during the healing process. Bilok® Screws are biodegradable and biocompatible.
BIOCOMPOSITES LTD
160-935T
In Commercial Distribution


  • Width: 9 Millimeter
  • Length: 35 Millimeter
160-935T

  • Bioabsorbable orthopaedic bone screw
The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok° Screw provides an interference fixation during femoral and/or tibial fixation in ACL reconstruction that resorbs and is replaced with bone during the healing process. Bilok® Screws are biodegradable and biocompatible.
BIOCOMPOSITES LTD
160-930T
In Commercial Distribution


  • Width: 9 Millimeter
  • Length: 30 Millimeter
160-930T

  • Bioabsorbable orthopaedic bone screw
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