CLA-2-30:OT:RR:NC:2:238
Ms. Melissa Traylor
FzioMed, Inc.
231 Bonetti Drive
San Luis Obispo, CA 93401
RE: The tariff classification of DYNAVISC®
Dear Ms. Traylor:
In your letter dated April 24, 2012, you requested a tariff classification ruling.
The subject product, DYNAVISC®, is an absorbable adhesion barrier, in the form of a clear viscoelastic sterile gel. The gel is composed of sodium carboxymethylcellulouse (CMC), polyethylene oxide (PEO), calcium chloride, sodium chloride and sterile water. It is intended to be placed around the tendon and peripheral nerve tissues to serve as a temporary mechanical barrier separating opposing tissue surfaces during the healing process. It is indicated to reduce fibrosis and formation of adhesion following tendon and/or peripheral nerve surgery. The gel is put up in a 1mL syringe that is fitted into a sterile polycarbonate thermoform tray. In addition, a sterile pouch containing a soft, flexible plastic applicator is provided as an attachment to the syringe for ease of administration of the gel into the surgical site. The sealed thermoform tray containing the gel, the plastic applicator and the instruction for use are packaged for retail sale to hospitals and healthcare professionals use only in a printed box.
The applicable subheading for the DYNAVISC® will be 3006.10.0100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Pharmaceutical goods specified in note 4 to this chapter: Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental hemostatics;
sterile surgical or dental adhesion barriers, whether or not absorbable.” 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).
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
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 Judy Lee at (646) 733-3033.
Sincerely,
Thomas J. Russo
Director
National Commodity Specialist Division