Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

cryolife medical (australia) company pty ltd - 44830 - applicator, surgical sealant, dual-channel - a dual channel device that enables a surgeon to apply with precision a two-component surgical adhesive to a surgical site. applicator tips are intended to be used only with the prefilled bioglue surgical adhesive (bioglue) cartridge/syringe(s) - they allow for the proper mixing of the bioglue implant material.

Singapur - İngilizce - HSA (Health Sciences Authority)

cryolife asia pacific pte ltd - cardiovascular - photofix is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

advanced biomedical pty ltd -

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

advanced biomedical pty ltd - 44830 - applicator, surgical sealant, dual-channel - a dual channel device that enables a surgeon to apply with precision a two-component surgical adhesive to a surgical site. applicator tips are intended to be used only with the prefilled bioglue surgical adhesive (bioglue) cartridge/syringe(s) - they allow for the proper mixing of the bioglue implant material.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

advanced biomedical pty ltd - 47784 - surgical adhesive/sealant, animal-derived - a two-component surgical adhesive composed of purified bovine serum albumin (bsa) and glutaraldehyde which is sterilised via gamma-irradiation. the solutions are dispensed by a controlled delivery system, applicator tips, and applicator tip extenders. the delivery device-mediated application is designed to provide reproducible mixing of the components in vitro. bioglue begins to polymerize within 20 to 30 seconds and reaches its bonding strength within 2 minutes. for use as an adjunct to standard methods of surgical repair to bond, seal and.or reinforce soft tissue.

Singapur - İngilizce - HSA (Health Sciences Authority)

cryolife asia pacific pte ltd - general & plastic surgery - bioglue surgical adhesive is indicated for use as an adjunct to standard methods of surgical repair (such as sutures, staples, and/or patches) to adhere, seal, and/or reinforce soft tissue. indicated soft tissues are cardiac, vascular, pulmonary, and dural.

Singapur - İngilizce - HSA (Health Sciences Authority)

cryolife asia pacific pte ltd - cardiovascular - for endovascular treatment of patients with: •unilateral or bilateral aorta-iliac or iliac aneurysm •suitable for endovascular repair •patient must be compliant with life-long follow-up investigations •>18 years old •iliac/femoral access vessel morphology compatible with the implantation procedure and the 18f (6mm od) delivery system •non-aneurysmal common iliac artery landing area in case of iliac artery aneurysm≥20mm •diameter of the common iliac artery in the proximal landing area: 12mm to 17mm •non-aneurysmal external iliac artery segment distal to the aneurysm≥15mm •diameter of the external iliac artery in the distal landing area: 8mm to 13mm •non-aneurysmal internal iliac artery segment distal to the aneurysm≥15mm •angle between external iliac artery and internal iliac artery≤50° •thrombus free iliac lumen in the area of iliac bifurcation to open side branch and to implant covered stent≥18mm •sufficiently open internal iliac artery ostium

Singapur - İngilizce - HSA (Health Sciences Authority)

cryolife asia pacific pte ltd - cardiovascular - the e-tegra stent graft system is indicated for the endovascular treatment of infrarenal aotic aneurysms which may also affect the common iliac artery provided the following preconditions are met: • suitable morphology of the iliac or femoral access vessels • length of the proximal landing zone in the infrarenal aorta ≥ 15 mm • angle of the infrarenal aorta distal to the landing zone ≤ 75° • diameter of the proximal landing zone 19 - 32 mm • length of the distal landing zone in the common iliac artery ≥ 15 mm • diameter of the distal landing zone in the common iliac artery 8 - 25 mm • vascular morphology suitable for the use of a stent graft

Singapur - İngilizce - HSA (Health Sciences Authority)

cryolife asia pacific pte ltd - general & plastic surgery - the e-wire guide wire is intended for the placement and replacement of catheters in diagnostic and interventional procedures, particularly for the treatment of abdominal and thoracic aortic aneurysms involving endovascular prostheses.

Singapur - İngilizce - HSA (Health Sciences Authority)

cryolife asia pacific pte ltd - cardiovascular - the flowline bipore eptfe vascular graft is indicated in cases of arterial reconstruction, primarily in the peripheral vascular region. it can also be used in extraanatomical reconstructions – femorofemoral and axillofemoral. standardwall flowline bipore prosthesis are also indicated for use as arteriovenous shunt prosthesis in haemodialysis.