THE PRODUCT IS A MEDICAL DEVICE, AND IS AN ACCESSORY WHICH IS FITTED TO AN ENDOSCOPE TO ASSIST WITH THE COMPLETE AND ACCURATE POSITIONING OF AN ENDOSCOPE IN THE LARGE INTESTINE. THE DEVICE ASSISTS WITH OPTICAL VISUALISATION, DIAGNOSIS, AND ENDOSCOPIC TREATMENT OF A PATIENT. IS A NON-STERILE, SINGLE USE, DISPOSABLE, LOOSE-FITTING SLEEVE THAT FITS OVER A STANDARD ENDOSCOPE THAT HAS A DISTAL TIP OUTER DIAMETER OF BETWEEN 12.5 - 14.3 MM AND A WORKING LENGTH OF 1680MM OR GREATER. THE DEVICE EMPLOYS 2 BALLOONS TO POSITION AND STABILISE THE ENDOSCOPE WITHIN THE PATIENT'S LARGE INTESTINE. ONE BALLOON IS BEHIND THE BENDING SECTION OF THE ENDOSCOPE (AFT BALLOON) AND THE SECOND IS IN FRONT OF THE TIP OF THE ENDOSCOPE (FORE BALLOON). WHEN BOTH BALLOONS ARE DEPLOYED AND INFLATED THE AREA IN BETWEEN IS STABILISED. THE BALLOONS CAN INFLATE UP TO 6CM IN DIAMETER. CONSISTS OF COMPONENT PARTS WHICH ARE DETAILED BELOW, TOGETHER WITH THE CORRESPONDING MATERIALS: THE BALLOONS, PUSH RODS, SLEEVE AND AFT BALLOON INFLATION TUBE MAY ALL CONTACT THE INSIDE OF THE LARGE INTESTINE DURING A MEDICAL PROCEDURE. COMPONENTS MATERIAL: BALLOON POLYURETHANE, LOW DUROMETER SLEEVE CORE EXTRUSION: PELLETHANE 2363-80A WITH 2.5% GLYCOTUBE TRANSLUCENT, PUSHROD COEXTRUSION INNER - PFA (PERFLUOROALKOXY), INFLATION COEXTRUSION INNER - PEBAX (POLYETHER BLOCK AMIDE) 7233 SA01 MED PUSH ROD ISOPLAST 2510 (POLYURETHANE) ADHESIVE DYMAX 208-CTH-F AFT BALLOON PELLETHANE 90A FORE BALLOON SADDLE TIP PEBAX 4033 SA01 MED IS PACKAGED IN A GLIDEX/CO-EX PETG TRAY (THERMOFORMED TRAY) AND LID SEALED WITH A COATED TYVEK COVER. THE TRAY IS PLACED IN A SHELF BOX TO FURTHER PROTECT THE DEVICE DURING TRANSPORTATION AND STORAGE. THE INSTRUCTIONS FOR USE ARE ALSO INSERTED INTO THE LABELLED SHELF BOX. THE PRODUCT HAS A SHELF LIFE OF SIX MONTHS.

CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING:- GENERAL INTERPRETATIVE RULES (GIR)S GIR 1 HAS BEEN USED TO CLASSIFY THIS PRODUCT BY THE TERMS OF HEADING 9018 INSTRUMENTS AND APPLIANCES USED IN MEDICAL, SURGICAL, DENTAL OR VETERINARY SCIENCES, INCLUDING SCINTIGRAPHIC APPARATUS, OTHER ELECTROMEDICAL APPARATUS AND SIGHT-TESTING INSTRUMENTS GIR 5 b HAS BEEN USED TO REFLECT THE NORMAL PACKAGING OF THESE GOODS. GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 901890 INTSTRUMENTS AND APPLIANCES CN CODE 90189020 ENDOSCOPES ALSO CLASSIFIED IN ACCORDANCE WITH NOTE 2B TO CHAPTER 90 HARMONISED SYSTEM EXPLANATORY NOTE (HSEN) O TO 9018 AND PARTS AND ACCESSORIES.