Singapore - English - HSA (Health Sciences Authority)

emergo singapore consulting private limited - orthopaedics - l&k biomed openloc-l spinal fixation system is intended for use as posterior pedicle screw fixation systems (t1-s2/ilium), or as an anterolateral fixation system (t8-l5). all components in the system are limited to skeletally mature patients and are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease, spondylolisthesis, trauma (fracture or dislocation), deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, stenosis, and pseudoarthrosis. it is indicated for the treatment of severe spondylolisthesis (grade 3 and 4) of the l5-s1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (l3 to sacrum) with removal of the implants after the attainment of a solid fusion .in addition, the system is intended to provide immobilization and stabilization of spinal segments

Singapore - English - HSA (Health Sciences Authority)

emergo singapore consulting private limited - orthopaedics - l&k biomed pathloc-l mis spinal system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. and the pathloc-l mis spinal system can be used in an open approach and a percutaneous approach. the pathloc-l mis spinal system is intended for the following indications: - degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - spondylolisthesis - trauma(i.e., fracture or dislocation) - spinal stenosis - curvatures(i.e., scoliosis, kyphosis, and for lordosis) - tumor - pseudarthrosis - failed previous fusion’.

Australia - English - Department of Health (Therapeutic Goods Administration)

hans biomed australia pty ltd - 16584 - suture, polydioxanone - the mint is made of ?olydioxanone. pdo has been found to be non-antigenic and to elicit only a slight tissue reaction during absorption. the dye is d&c violet no.2. mint is eo sterilized and degrades or dissolves over time in tissue. each suture has bi-directional barbs along the long axis of the monofilament without needle attachment. mint approximates tissue, without the need to tie surgical knots, by using the barbs on the suture surface to embed in the tissues after suture placement. the mint is comprised of pdo and indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Australia - English - Department of Health (Therapeutic Goods Administration)

hans biomed australia pty ltd - 16584 - suture, polydioxanone - a sterile single- use polydioxanone suture with type 2 needle. the pigment for the violet dye is d&c violet no.2. mint is eo sterilized and degrades or dissolves over time in tissue. each suture has bi-directional barbs along the long axis of the monofilament without needle attachment. mint approximates tissue, without the need to tie surgical knots, by using the barbs on the suture surface to embed in the tissues after suture placement. mint polydioxanone absorbable surgical suture is intended for correction of defected soft tissue caused by accidents or trauma. mint is inserted under a local anaesthesia in the skin and gently pulled into position, placing a barbed suture under the skin. the suture lifts tissues that have defects.

Australia - English - Department of Health (Therapeutic Goods Administration)

hans biomed australia pty ltd - 16584 - suture, polydioxanone - the mint synthetic absorbable pdo suture is made of ?olydioxanone, and is supplied with attached needles. the pigment for the violet dye is d&c violet no.2. mint is eo sterilized and degrades or dissolves over time in tissue. each suture has bi-directional barbs along the long axis of the monofilament without needle attachment. mint approximates tissue, without the need to tie surgical knots, by using the barbs on the suture surface to embed in the tissues after suture placement. mint polydioxanone absorbable surgical suture is intended for correction of defected soft tissue caused by accidents or trauma. mint is inserted under a local anaesthesia in the skin and gently pulled into position, placing a barbed suture under the skin. the suture lift tissues that have defects.

New Zealand - English - Medsafe (Medicines Safety Authority)

biomed limited - monosodium glutamate 10.67 g;  ; sodium aspartate 9.87 g;   - solution for infusion - active: monosodium glutamate 10.67 g   sodium aspartate 9.87 g   excipient: water for injection - compounding solution for pulmonary bypass machine

New Zealand - English - Medsafe (Medicines Safety Authority)

biomed limited - citric acid monohydrate - diluent - 0.07 % - excipient: citric acid monohydrate purified water

New Zealand - English - Medsafe (Medicines Safety Authority)

biomed limited - calcium chloride dihydrate 6.95 g/l (formula n); glacial acetic acid 6.01 ml (formula n); glucose (formula n); magnesium chloride hexahydrate 3.77 g/l (formula n); potassium chloride 3.91 g/l (formula n); sodium chloride 210.65 g/l (formula n) - dialysis solution - active: calcium chloride dihydrate 6.95 g/l (formula n) glacial acetic acid 6.01 ml (formula n) glucose (formula n) magnesium chloride hexahydrate 3.77 g/l (formula n) potassium chloride 3.91 g/l (formula n) sodium chloride 210.65 g/l (formula n) excipient: water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

biomed limited - calcium chloride dihydrate 8.49 g/l (formula o); glacial acetic acid 8.8 ml (formula o); glucose (formula o); magnesium chloride hexahydrate 4.7 g/l (formula o); potassium chloride 3.91 g/l (formula o); sodium chloride 167.69 g/l (formula o) - dialysis solution - active: calcium chloride dihydrate 8.49 g/l (formula o) glacial acetic acid 8.8 ml (formula o) glucose (formula o) magnesium chloride hexahydrate 4.7 g/l (formula o) potassium chloride 3.91 g/l (formula o) sodium chloride 167.69 g/l (formula o) excipient: water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

biomed limited - calcium chloride dihydrate 8.49 g/l (formula s); glucose (formula s); magnesium chloride hexahydrate 4.7 g/l (formula s); potassium chloride 3.91 g/l (formula s); sodium acetate 129.56 g/l (formula s); sodium chloride 194.11 g/l (formula s) - dialysis solution - active: calcium chloride dihydrate 8.49 g/l (formula s) glucose (formula s) magnesium chloride hexahydrate 4.7 g/l (formula s) potassium chloride 3.91 g/l (formula s) sodium acetate 129.56 g/l (formula s) sodium chloride 194.11 g/l (formula s) excipient: water for injection