Address:KEELE SCIENCE PARK,Keele Staffordshire,GB
Device Description : Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for sing Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for sing Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for sing Stimulan® Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Calcium Sulfate Bone Filler is manufactured from medical grade calcium sulfate dihydrate (CaSO4 2H20) and stearic acid that resorbs and is replaced with bone during the healing process. Also as the bone void filler pellets are biodegradable and biocompatible, they may be used at an infected site.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit 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 injected or 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® Kit 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.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit contains STIMULAN® Kit - provided sterile for single patient use. STIMULAN® Kit 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 injected or 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® Kit 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.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : geneX® is a simple to use synthetic resorbable material designed to promote rege 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.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. geneX® is supplied sterile
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : geneX® is a simple to use synthetic resorbable material designed to promote rege 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.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. geneX® is supplied sterile
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Pu geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It 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. geneX® Putty is a non-setting putty and is supplied sterile.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes