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The I-Style Bone Marrow Aspiration Needle with T-Handle is intended for aspiration of bone marrow.

The I-Style Bone Marrow Aspiration Needle with T-Handle consists of a 15G and 18G needle with a triple sharpened atraumatic tip stylet of corresponding size all made of AISI 304 Stainless steel. The needle has an ergonomic grip at whose base a Luer-Lock cone in fitted. The innovative element of the needle is a removable spacer, which indicates the depths the tip can reach. Using a depth stopper, easy adjustment of the needle length, making it easier to reach the tissue to be examined.

Busse Surgical Drape IV is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide.

Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. This is the same intended use as a previously cleared for the Busse Surgical Drape II, K083424.

The Laminated Non-Woven Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

The Busse Surgical Drape is intended for external use only and is used is as a protective patient covering, such as to isolate a site of surgical incisions from it a vacu is a a provided steries using ethylene oxide.

Surgical drapes are intended to provide protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

specialty needles - Spinal Needle, Pencil Point Needle, and Epidural Needle - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Anesthesia conduction needles consist of different styles. All the needles consist of a plastic or K-Resin hub connected to a stainless steel cannula. Some of the needles have stylets made of the same steel whereas others have stylets made of plastic. Some of the needles have wings, which can be attached to the hub for more stability depending on user procedure. The needles have been categorized as following: 1. Spinal Needles (Quincke) 2. Pencil Point Spinal Needle (Whitacre) 3. Epidural Needles (Tuohy & Hustead) The differences between the styles of needles are the tip of the needle, which is pencilpoint-tip (Whitacre), curved and sharp needle (Toulty) or sharp needle tin (Quincke)

The Epidural Catheter is intended for administration of local anesthetics into the epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.

The Busse Epidural Catheter is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The Catheter will also be sold as a non-sterile product to kit packers, who then may sterilize the catheter as part of a kit.

The Glass Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique; it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit.

The Glass Loss of Resistance Syringe is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip tip.

specialty needles – Spinal Needle, Pencil Point Needle, and Epidural Needle - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Anesthesia conduction needles consist of different styles. All the needles consist of a plastic hub connected to a stainless steel cannula. Some of the needles have stylets made of the same steel whereas others have stylets made of plastic. Some of the needles have wings which can be attached to the hub for more stability depending on user procedure. The needles have been categorized as following: 1. Spinal Needles (Quincke) 2. Pencil Point Spinal Needle (Whitacre) 3. Epidural Needles (Tuohy & Hustead) The differences between the styles of needles are the tip of the needle, which is either pencil-point-tip (Whitacre), curved and sharp needle (Touhy), sharp needle tip (Quincke). These needles will be provided as sterile, single use, disposable devices. They will be packaged individually or included in regional anesthesia trays.

The I-Style Bone Marrow Aspiration Needle is intended for Aspiration of Bone Marrow.

The I-Style Bone Marrow Aspiration Needle consists of an 8ga - 15ga needle and a triple sharpened atraumatic tip stylet of corresponding size. The needle is manufactured in lengths upto 2" with an adjustable depth stopper and graduated scale which allow for the adjustment of the penetration length of the needle. A luer lock connection is provided in the molded needle handle to allow aspiration of bone marrow or blood by use of a standard surgical syringe. The needle will be provided as sterile, single use, disposable device. They will be packaged individually or included in Bone Marrow Biopsy Tray.

The Needle Stick Block is a single needle holder to be used after the needle is removed from the patient and until it can be properly disposed, therefore, aiding in the prevention of needle stick injuries. The Needle Stick Block is a safety device designed to help the health care facilities to minimize the risk of needle sticks. Busse Hospital Disposable intent to sell this device individually and as part of safety trays in which needle is involved. The intended use will remain the same whether is sold individually or as part of a tray.

Sterile/ Latex Free/ Needle Stick Block. The proposed Needle Stick Block was created to help prevent needle sticks by providing a means of moving used sharps from procedure and hold it temporarily until procedure is completed to then be disposed off in a sharps container.