Non-Articulated and Sharp Surgical Instrument - Stainless Steel – Sterile

The commercial models of the Non-Articulated Cutting Surgical Instrument - Stainless Steel - Sterile family are instruments used in orthopedic trauma surgery on the human body.

The instruments are classified as Risk Class I, that is, transient-use surgical instruments designed exclusively to assist in orthopedic surgery.

These instruments must not be used for surgeries or purposes other than those indicated in this document.

The instruments are single-use and must be discarded after surgical use. The correct disposal method is described in the Instrument Disposal section.

The commercial models that make up the Non-Articulated Cutting Surgical Instrument - Stainless Steel - Sterile family are made available for sale individually packaged, as Sterile products.

The instruments are packed in a double Blister-type package (primary packaging) manufactured from non-toxic PET (Poly(Ethylene Terephthalate)) film, suitable for contact with hospital products. The blister package is sealed with surgical-grade paper, free of dyes and holes, through a duly validated heat-sealing process.

The double Blister-type package is placed in an outer cardboard package (secondary packaging) together with two traceability labels. A green label is affixed to the secondary packaging, indicating that the product is Sterile, as well as information on the lot, sterilization date, expiration date, company, CNPJ and technical manager of the institution that performed the sterilization.

Sterile Product - Sterilized by Ethylene Oxide - EO.

The commercial models of the Non-Articulated Cutting Surgical Instrument - Stainless Steel - Sterile family are indicated for use in orthopedic trauma surgery on the human body, with the purpose of assisting the surgeon in specific surgical procedures, such as:

Closed and/or open fractures;

Degenerative instabilities;

Revision surgeries, such as implant replacement or removal;

• Tumor resection and
• Arthroscopic Hip Surgery for Capsulotomy.

Stainless Steel