CLA-2-30:OT:RR:NC:N2:238
Ms. Melissa M. Traylor
FzioMed, Inc.
231 Bonetti Drive
San Luis Obispo, CA 93401
RE: The tariff classification of Oxiplex® Gel
Dear Ms. Traylor:
In your letter dated October 21, 2009, you requested a tariff classification ruling.
The subject product, Oxiplex® Gel, is an absorbable adhesion barrier, in the form of a clear, synthetic, sterile gel. The gel is composed of polyethylene oxide (PEO) and sodium carboxymethylcellulose (CMC). Calcium chloride and sodium chloride are added for stability. Oxiplex® Gel is intended to be placed at sites of tissue injury in the epidural space following laminectomy, laminotomy, and/or discectomy to serve as a temporary mechanical barrier separating opposing tissue surfaces. It is indicated for use as an adjunct to posterior lumbar laminectomy, laminotomy, or discectomy procedures for reducing pain, radiculopathy, lower extremity weakness, and the incidence, extent and posterity of postoperative adhesions. The gel is put up in a 3mL syringe that, together with a sterile, 5.42" plastic applicator and instructions for use, is fitted into a sterile, thermoform (plastic) tray. The tray, in turn, is put up packaged for retail sale in a printed box.
The applicable subheading for the Oxiplex® Gel 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 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.
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 Harvey Kuperstein at (646) 733-3033.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division