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STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

The STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable single-use surgical suture device composed of a copolymer of glycolide and (epsilon) s-caprolactone. The device contains IRGACARE®: MP (triclosan), a broad-spectrum antibacterial agent, at no more than 2360 ug/m. The colorant employed is D&C Violet No.2, in <0.050% w/w concentration. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption. The subject device is intended for professional use only. Same as the currently marketed undyed version, the subject device consists of a unidirectional barbed suture material, armed with a surgical needle on one end and an anchoring fixation loop at the opposite end. The barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots. While the formation of barbs in the subject STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Device can be compared to USP knot strength of non-barbed sutures. The actual diameter of the non-barbed section fiber is one size greater than the designated size with a maximum overage of 0.1 mm. The subject device is sterilized by Ethylene Oxide, and is available in lengths of 6, 9, and 12 inches, with a USP diameter size 2-0 and 3-0 (metric sizes 3.0 and 2.0), and single armed with various needle sizes.

PDS™ Plus Suture is indicated for use in general soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur. PDS™ Plus Suture is not indicated in adult cardiovascular and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

PDS™ Plus Antibacterial Suture is a sterile synthetic absorbable monofilament suture made from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C4H6O3)n. PDS™ Plus Antibacterial Suture is available undyed and dyed with D&C Violet No. 2 PDS™ Plus Antibacterial Suture contains Irgacare®† MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 ug/m.

DERMABOND™ PRINEO™ System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND™ PRINEO™ System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND PRINEO System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties. DERMABOND PRINEO also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liquid topical skin adhesive is applied to achieve skin closure.

The absorbable VICRYL™ Mesh may be used wherever temporary wound support is required. VICRYL™ Mesh may be cut to the shape or size desired for each specific application.

VICRYL™ (polyglactin 910) Mesh is a synthetic absorbable sterile copolymer made from glycolide and L-lactide. The copolymer is identical in composition to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture. Two weave configurations are available, knitted and woven. VICRYL™ Knitted Mesh is more porous than VICRYL™ Woven Mesh and may be used in instances in which compliant and stretchable support material is desired.

STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Devices is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

The STRATAFIX™ Spiral PDS™ Plus Bidirectional Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HzO3)y. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption. The STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The STRATAFIX™ Spiral PDSTM Plus Device barbs allow for tissue approximation without the surgical knots.

VICRYL™ Mesh may be used wherever temporary wound or organ support is required (kidney, liver, spleen). VICRYL™ Mesh may be cut to the shape or size desired for each specific application.

VICRYL™ (polyglactin 910) Mesh is a synthetic absorbable sterile copolymer made from glycolide and L-lactide. The copolymer is identical in composition to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture. VICRYL™ Knitted Mesh, which is more porous than VICRYL™ Woven Mesh, may be used in instances in which compliant and stretchable support material is desired.

VICRYL™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PDSTM II Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS™ II Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable. PDSTM Plus Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS™ Plus is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

VICRYL™ (Polyglactin 910) Suture is a sterile, synthetic, absorbable, surgical suture composed of a copolymer made of 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. VICRYL™ Suture is available as a coated or an uncoated suture. VICRYL™ Suture is coated with a mixture composed of equal parts of copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and Polyglactin 370 with calcium stearate have been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption. VICRYL™ Suture is available undyed and dyed with D&C Violet #2 (Color Index 60725) to enhance visibility in the surgical field. VICRYL™ Suture is available in a range of gauge sizes and lengths, types and sizes, and in presentations non-needled or attached to needles of various types and sizes. PDSTM II (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HoO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption. PDS™ II Suture is available undyed and dyed with D&C Violet Number 2 (Color Index 60725) to enhance visibility in the surgical field. PDS™ II Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes. PDSTM Plus Antibacterial (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture made from the polyester poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HaO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption. PDS™ Plus Suture is available undyed and dyed with D&C Violet No. 2 (Color Index 60725) to enhance visibility in the surgical field. PDS™ Plus Suture contains Irgacare® : MP (triclosan), a broad-spectrum antibacterial agent at no more than 2360 µg/m. PDSTM Plus Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of varying types and sizes.

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate. STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from the polyester, poly (pdioxanone). The empirical molecular formula of the polymer is (C+HgO3). The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is dyed with D&C Violet No. 2. STRATIX™ Symmetric PDS™ Plus Knotless Tissue Control Device consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. Polydioxanone has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption. STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HgO3)x. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption. The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots. While the formation of barbs in the STRATAFIX™ Spiral PDS™ Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDSTM Plus Device can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDS™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm. STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. The device contains IRGACARE® MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360ug/m. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption. The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots. While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1mm. STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is a monofilament. synthetic absorbable device prepared from a copolymer of glycolide and e-caprolactone. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption. The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Device is designed to anchor with a closed loop at one end and unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots. While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Device reduces tensile strength relative to non-barbed suture material of the same size, tving of knots in non-barbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1mm.

Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.

Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is a sterile, synthetic absorbable surgical suture (dyed and undyed) and is composed of a copolymer made from 90% glycolide and 10% L-lactide. Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The suture contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 472 µg/m. The copolymers in the product have been found to be nonantigenic, nonpyrogenic and elicit only a mild tissue reaction during absorption. The suture is available undyed(natural) or dyed (D&C Violet No. 2).

Temporary Cardiac Pacing Wire is intended for use in temporary epicardial cardiac pacing or monitoring and should be removed after temporary pacing has been discontinued.

The Temporary Cardiac Pacing Wire is a sterile single-use product. Temporary cardiac pacing wires consist of the following configurations and optional accessories: 1. The monopolar leads consist of one insulated multifilament stainless steel conductor coated with colored polyethylene. 2. The intracorporeal end of the wire has a section of exposed, uninsulated wire electrode which terminates with an attached stainless steel needle. 3. The exposed, uninsulated section of the intracorporeal end of the wire is either straight or has one or more multiple pre-formed curves (pre-formed wave). 4. The extracorporeal end of wire has a straight needle with breakaway tip attached. 5. The wire length is 60 cm. 6. Wires range in multiple diameters from 0 to 2-0, depending on the product code.