CLA-2-90:OT:RR:NC:N1:405

Mr. Mark Pinchok
Bayer International Trade Services Corporation
651 Colliers Way, Suite 414
Weirton, PA 26062

RE: The tariff classification of the Essure System from Mexico

Dear Mr. Pinchok:

In your letter dated January 7, 2014, on behalf of your client Bayer HealthCare LLC, you requested a tariff classification ruling.

The merchandise under consideration is referred to as the Essure system which is a surgery-free trans-cervical sterilization device and corresponding procedure for a woman that provides permanent birth control. The Essure system mainly consists of the catheter, sheath, and inserts in one packaged system (box) for the doctor to perform the procedure.

The procedure involves small, flexible inserts referred to as the Essure inserts that are placed into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus. The Essure insert contains inner polyethylene terephthalate fibers to induce a benign fibrotic reaction and is held in place by a flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil. Once in place, the device is designed to elicit tissue in-growth in and around the insert over a period of three months to form an occlusion or blockage in the fallopian tubes. The tissue barrier formed prevents sperm from reaching an egg thus resulting in permanent contraception. The applicable subheading for the Essure System will be 9018.39.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: Syringes, needles, catheters, cannulae and the like and parts and accessories thereof: Other, Other. The rate of duty will be free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Barbara Kiefer at (646) 733-3019.

Sincerely,

Gwenn Klein Kirschner
Acting Director
National Commodity Specialist Division