Search Results

Indications for Use: Polyurethane probe covers are indicated during diagnostic ultrasound procedures in cases where patient sensitivity to latex is speculative.

The Sheathing Technologies, Inc Ultrasound Probe Cover provides a thin, conformal covering to fit various and specific ultrasound transducer shapes. The cover is made in a general cylindrical shape. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer. This device is an accessory used on diagnostic probes to help minimize cross contamination. The cover material is a polyether-based polyurethane. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations. Product categories/models include - General Purpose Sheathes Ultrasound 1. Probe Covers (sterile and non-sterile) Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities. The sole difference between this device and the predicate is a labeling change (addition of "viral barrier" to labeling, based on bench testing) to our line of seamless and seamlesstipped ultrasound probe covers. Please see section 13, labeling, for full wording. Please note that seamless and seamless-tipped probe covers are only a subset of the product line. The labeling for the remaining products would remain unchanged.

Sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended for non-invasive use in medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or fluid.

Sheathing Technologies, Inc Ultrasound Gel is a water-based coupling agent for diagnostic ultrasonic procedures. This device is an accessory used on diagnostic ultrasound probes. The material is a water-based gel. Gel will be sold in sterile packets for single patient/procedure, disposable use.

Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or fluid.

Sheathing Technologies, Inc Ultrasound Gel is a water-based coupling agent for diagnostic ultrasonic procedures. This device is an accessory used on diagnostic ultrasound probes. The material is a water-based gel. Product categories/models include Individual packets (non-sterile) and Bulk bottles (non-sterile). Gel is for single patient/procedure, disposable use.

Colonoscope/Sigmoidoscope Sheaths are meant for use in non-sterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.

The Sheathing Technologies, Inc. Polyurethane Colonoscope/Sigmoidoscope Sheath provides a conformal covering to fit various lengths and widths of colonoscopes and sigmoidoscopes (hereafter referred to as 'endoscopes'). The cover is open at the proximal end to allow free use of the endoscope's channels, and open at the distal end for insertion of the endoscope. Various sizes and shapes of Sheaths are offered to address the variations in size of the endoscopes. This device is an accessory for use in nonsterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure. The cover material is a polyether-blend polyurethane, which is the same blend currently used for Sheathing Technologies probe covers (510(K) K963831 for Sheathes Non-Latex, Non-Sterile and 510(K) K990175 for Sheathes Non-Latex, Sterile). Product categories/models include - Rigid sigmoidoscope Sheaths (sterile and non-sterile) - Flexible sigmoidoscope Sheaths (sterile and non-sterile) - Colonoscope Sheaths (sterile and nonsterile) Sheaths are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities. All are intended for non-sterile procedures, and all are for single patient/procedure, disposable use.

Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative.

The Sheathing Technologies, Inc CIS-Isoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer shapes. The cover is made by dipping to form a general cylindrical shape. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer. This device is an accessory used on diagnostic probes to help minimize cross contamination. The cover material is a Cis-1,4-polyisoprene, a synthetic version of natural rubber latex made without using natural rubber latex in the formulation. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations. Product categories/models include General Purpose SheathesISO Ultrasound Transducer Covers (sterile and non-sterile). Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities, as well as in "procedure kit" form for single patient/procedure, disposable use. The "procedure kit" may include elastic fasteners, with or without coupling gel packets. Transducer covers are also combined with disposable needle guide devices into kits.

The Sheathes Needle Guide provides guidance for a needle, catheter, biopsy apparatus, or other interventional device by positioning it relative to the ultrasound apparatus, of other moreman as aring a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement.

The Sheathes Needle Guide system consists of 4 primary components which are used to provide interventional tool in relation to the ultrasound image. Three components (a transducer cover, a guide clip, and retainer clip) are single use disposable, while the fourth component, the adapter, is a reusable component, providing a system interface to various transducers.

STERILE NON-LATEX PROBE COVERS ARE INDICATET) DURING DIAGNOSTIC ULTRASOUND PROCEDURES in CASES WHERE.. PATIENT SENSITIVITY TO LATEX is SPECULATIVE.

Sheathes (Non-Latex), Sterile