ClotIt Vet Hemostatic Gauze

Superior Science. Superior Clotting.

Sterile, Multi-Segmented, Impregnated Hemostatic Gauze

For surgical and dental procedures and or minor to severe animal wounds.

Instructions for Use for General Surgical & Dental Applications

1. Open foil pouch.

2. Choose appropriate gauze segment and tear from sheet.

3. Apply gauze, covering the entire wound.

4. Apply moderate pressure for 10 - 20 seconds (longer for severe wounds).

5. Repeat as needed.

Severe wounds may require multiple applications. Use caution when applying in direct contact with large vessels and seek veterinary care before closing wound site.

Description

ClotIt VET Hemostatic Gauze is a medical device designed for application to wound sites as a hemostat. ClotIt VET Hemostatic Gauze ia gauze with all-natural minerals coated on top. The hydrophilic particles on the gauze work to rapidly absorb plasma at the wound site. This gauze rapidly initiates clotting and stops bleeding. This product does not contain any human or animal components. It is a sterilized, white, perforated gauze and is non-pyrogenic, non-cytotoxic, and biocompatible.

Action

ClotIt VET Hemostatic Gauze consists of hydrophilic molecules that enhances natural hemostasis by ionically attracting blood particles such as platelets, red blood cells, and blood proteins and activating factor XII of the coagulation cascade to greatly speed up the body’s own natural clotting process.

ClotIt Vet Hemostatic Gauze Indications

ClotIt VET Hemostatic Gauze is indicated in medical procedures and dental applications (except ophthalmic) as an adjunctive hemostatic device to assist when control of bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.

Sterility of Product

Any unused segments of ClotIt VET Hemostatic Gauze are rendered non-sterile. These segments may be reused for external wounds, or other situations where sterility is required.

Warnings

● ClotIt VET Hemostatic Gauze is not intended as a substitute for meticulous surgical technique and proper application of ligatures or other conventional procedures for hemostasis.

● Once hemostasis is achieved, ClotIt VET Hemostatic Gauze should be removed from the site of application.

● Wound site and surrounding tissue may darken after the use of ClotIt VET Hemostatic Gauze due to oxidation of hemoglobin resulting in the formation of met-hemoglobin, which is harmless.

USE CAUTION WHEN APPLYING IN DIRECT CONTACT WITH LARGE VESSELS AND ENSURE PROPER BLOOD FLOW IS REESTABLISHED PRIOR TO CLOSING THE WOUND SITE.

● ClotIt VET Hemostatic Gauze should be used with caution in the presence of infection or in contaminated areas of the body. If signs of infection or abscess develop where ClotIt VET Hemostatic Gauze has been applied, additional treatment may be necessary in order to allow drainage.

● Safety and effectiveness in ophthalmic or neurologic procedures have not been established.

● ClotIt VET should not be used for controlling post-partum bleeding or menorrhagia.

Precautions

● When using ClotIt VET Hemostatic Gauze to treat hemorrhaging in large vessels, ensure blood flow is restored prior to closing the wound site.

● ClotIt VET Hemostatic Gauze is supplied as a sterile product and cannot be re-sterilized. Unused pieces of ClotIt VET Hemostatic Gauze should be discarded or reused in ways that do not require sterility, e.g. external wounds.

● When ClotIt VET Hemostatic Gauze is used in conjunction with autologous blood salvage circuits, carefully follow the instructions in the administration section regarding proper filtration and cell washing.

● ClotIt VET Hemostatic Gauze is not recommended for the primary treatment of coagulation disorders.

● No testing has been performed on the use of ClotIt VET on bone surfaces to which prosthetic materials are to be attached with adhesives and is therefore not recommended.

● In urological procedures, ClotIt VET Hemostatic Gauze should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.

● If the wound has not completely stopped bleeding after the first use, use another gauze segment and reapply ClotIt VET Hemostatic Gauze to the wound site.

● In situations where the gauze sticks to the wound site, moisten the gauze with saline solution and remove the gauze from the wound site.

Adverse Reactions That Have been Attributed To Other Hemostatic Agents

The following adverse events have been reported for other hemostatic agents and may apply to the use of ClotIt VET:

● Paralysis and nerve damage have been reported when hemostatic agents are used in or in proximity to foramina in bone, areas of boney confine, the spinal cord, and/with laminectomy, reports of paralysis have also been received in connection with other procedures.

● Compression of the brain and spinal cord resulting from the accumulation of sterile fluid has been observed.

www.clotitvet.com

One 4” x 3” Sterile, Multi-Segmented Gauze Application

STERILE R

Protégé Biomedical, LLC, 10909 Valley View Road, Eden Prairie, MN 55344

PRO-018-August 2018

©2018 Protégé Biomedical, LLC. All Rights Reserved

CPN: 1838002.0