CYTOPLAST OS-CS0618PERIO Non-Absorbable PTFE Sutures Instruction Manual

: June 3, 2024
: CYTOPLAST

Table of Contents

CYTOPLAST OS-CS0618PERIO Non-Absorbable PTFE Sutures
Introduction
Description
Precautions
Sterility
Storage
Labeling Symbols
ABOUT COMPANY
References
Read User Manual Online (PDF format)
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CYTOPLAST OS-CS0618PERIO Non-Absorbable PTFE Sutures

CYTOPLAST OS-CS0618PERIO Non-Absorbable PTFE Sutures-
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Introduction

The user of Cytoplast™ products has the duty to determine whether or not any product is suitable for the particular patient and circumstances. Osteogenics Biomedical disclaims any liability, express or implied, and shall have no responsibility for any direct, indirect, punitive or other damages, arising out of or in connection with any errors in professional judgment or practice in the use or installation of Cytoplast™ products.
IMPORTANT: Read this entire package insert prior to use and follow all instructions carefully.

Description

Cytoplast™ PTFE Suture is a nonabsorbable, monofilament suture manufactured from 100% high-density polytetrafluoroethylene (PTFE) polymer, extruded in such a fashion as to produce a structure with a minimal pore size and volume while maintaining integrity and tensile strength. The suture is undyed and contains no additives.

Actions

PTFE has been shown in clinical trials to elicit minimal tissue reaction. The Cytoplast™ PTFE Suture is not absorbed or subject to weakening by tissue enzymes, and does not degrade in the presence of infection.

Indications

The Cytoplast™ PTFE Suture is indicated for use in most types of soft tissue approximation and/or ligation, including dental surgeries. Cytoplast™ PTFE suture is designed for short-term use and must be removed. The device is not indicated for use in cardiovascular surgery, ophthalmic surgery, microsurgery, and central/peripheral neural tissue surgery.

Contraindications

There are no known contraindications.
Warnings:

The safety and effectiveness of this suture in ophthalmic, microsurgical, and peripheral neural applications has not been established.
Tissue invasion of Cytoplast™ PTFE Suture can result in attachment of the suture to the tissue it penetrates in long-term use. Such attachment may make removal of the suture difficult.
The device is for single use only. Do not resterilize.

Precautions

Misuse of this suture, like any other suture, can result in severe injury or death to the patient. As with any suture, care should be taken to avoid damage when handling. Avoid crushing or crimping the suture with surgical instruments or exposing the suture to sharp edges. In order to minimize needle damage, do not grasp or drive the needle from near the channel where the suture is attached.
Knot security requires standard surgical techniques of flat and square ties with additional throws as indicated by surgical circumstances and the experience of the surgeon. When tying knots with the Cytoplast™ PTFE Suture, tension should be applied by pulling each strand of the suture in opposite directions with equal force. Caution: this tension should not be applied by pulling on the needle itself, but is applied by grasping the suture with the fingers or surgical instruments. As the knot is tensioned, the air in the suture is forced out. Care should be taken to avoid using a jerking motion, which could break the suture or cause separation of the suture from the needle. Uneven tensioning of a well-formed square knot may result in an unsecure knot. When the Cytoplast™ PTFE Suture is properly tensioned and formed, standard surgical knotting techniques will produce a secure knot.

Sterility

Cytoplast™ PTFE Suture is supplied STERILE unless the integrity of the package has been compromised. The device is for single use only. Do not resterilize.

Adverse Reactions

None reported.

Dosages and Administration

Use as required per surgical procedure.

Storage

The product should be stored at room temperature.

How Supplied

Cytoplast™ PTFE Suture is available as sterile strands in a variety of sizes and lengths with permanently attached needles.
Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician or dentist.