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Mechanism of Action

Mechanism
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See how FLOSEAL works to stop bleeding fast.

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See how FLOSEAL works to stops bleeding fast.

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Clinical Information

Floseal Clinical Evidence

Learn more about FLOSEAL, from clinical results to hemostatic success.

Detailed Important Risk Information

FLOSEAL Hemostatic Matrix Indication

FLOSEAL Matrix is indicated in surgical procedures (other than ophthalmic) as an adjunct tohemostasis when control of bleeding by ligature or conventional procedures is ineffective orimpractical.

Important Risk Information for FLOSEAL Matrix

Do not inject or compress FLOSEAL Matrix into blood vessels. Do not apply FLOSEAL Matrix in the absence of active blood flow, e.g., while the vessel is clamped or bypassed, as extensive intravascular clotting and even death may result.

Do not use FLOSEAL Matrix in patients with known allergies to materials of bovine origin. Do not use FLOSEAL Matrix in the closure of skin incisions because it may interfere with the healing of the skin edges.

FLOSEAL Matrix contains Thrombin made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

FLOSEAL Matrix is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.

Excess FLOSEAL Matrix (material not incorporated in the hemostatic clot) should always be removed by gentle irrigation from the site of application.

FLOSEAL Matrix swells by approximately 10% to 20% after product is applied. Maximum swell volume is achieved within about 10 minutes.

The safety and effectiveness of FLOSEAL Matrix has not been established in children under 2 years of age and pregnant women.

Do not use air to remove residual FLOSEAL Matrix from Applicator tip. The Applicator tips should not be cut. Do not use FLOSEAL Matrix on bone surfaces where adhesives, such as methylmethacrylate or other acrylic adhesives, will be required to attach a prosthetic device.

Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.

View Instructions for Use »



Malleable Tip Endoscopic Applicator Indication (0600127)

The Malleable Tip Endoscopic Applicator is intended for use in delivering a hemostatic agent to bleeding sites through a 5 mm or larger diameter trocar.

Malleable Tip Endoscopic Applicator Important Risk Information

Read the hemostatic agent instructions for use prior to using this device.
Do not use if damaged.
Do not use air as a propellant to extrude hemostatic agents instead of the stylet.
Do not use Malleable Tip Endoscopic Applicator to manipulate or retract organs or tissue.
Do not bend the malleable tip against organ or tissue.
The Malleable Tip Endoscopic Applicator should only be used by persons adequately trained in Minimally Invasive surgical procedures.
Do not reuse or resterilize. Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
Rx Only: For safe and proper use of this device, please refer to full device Instructions for Use.

View Instructions for Use »



Endoscopic Applicator Indication (0600125)

The Endoscopic Applicator is intended for use in delivering hemostatic agent to bleeding surgical sites through a 5 mm or larger trocar.

Endoscopic Applicator Important Risk Information

Do not use if damaged.
Do not use air as a propellant to extrude hemostatic agents instead of the stylet. Do not use Endoscopic Applicator to manipulate or retract organs or tissue.
The Endoscopic Applicator should only be used by persons adequately trained in Minimal Invasive procedures.
Do not reuse or resterilize. Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.
Rx Only: For safe and proper use of this device, please refer to full device Instructions for Use.

View Instructions for Use »



FLOSEAL Special Applicator Tips Indication (1502186)

The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL Hemostatic Matrix.

Important Risk Information for FLOSEAL Special Applicator Tips

Do not use the FLOSEAL Malleable Tip and Trimmable Tip if the packaging is visibly damaged or if the tips are cracked.
Do not use air to remove residual FLOSEAL from the tip.
The FLOSEAL Malleable Tip and Trimmable Tip should only be used with FLOSEAL Hemostatic Matrix.
Read instructions for FLOSEAL Hemostatic Matrix prior to use.
The Malleable Tip should not be cut.
The Trimmable Tip should be trimmed away from the surgical cavity. Excess tip material should be collected in the inner pouch to discard.
Do not resterilize. Single-use only. Immediately discard after use.
RX only: For safe and proper use of these devices, please refer to full device Instructions for Use.

View Instructions for Use »



Curved Applicator Tips (8 cm: 934208, 10 cm: 934210)

This applicator tip is intended for use for delivering hemostatic agents that can be mechanically mixed and delivered to bleeding sites.

View Instructions for Use »