Address:KEELE SCIENCE PARK,Keele Staffordshire,GB
Device Description : Stimulan® DS Calcium Sulfate Bone Void Filler is provided sterile for single pat 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.
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. 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.
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. 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.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : The STIMULAN® Bullet Mat and Introducer is a surgical instrument whcih includes The STIMULAN® Bullet Mat and Introducer is a surgical instrument whcih includes a mat for preparation of the STIMULAN® bullets, a 7mm introducer, a 9mm introducer and an obturator for hard to reach defects. To be used with 20cc Stimulan Rapid Cure
Device Class : 1
Duns Number: 424382307
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Genex® Bone Graft Substitute is a simple to use synthetic resorbable material de Genex® Bone Graft Substitute 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® Bone Graft Substiute, a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes
Device Description : Genex® Bone Graft Substitute is a simple to use synthetic resorbable material de Genex® Bone Graft Substitute 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® Bone Graft Substitute a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile.
Device Class : 2
Duns Number: 424382307
Premarket Exempt : No
Prescription Use : Yes