CLA-2-30:OT:RR:NC:N1:138
Ms. Freya S. Wilkes
Allergan
2525 Dupont Drive
P.O. Box 19534
Irvine, CA 92623-9534
RE: The tariff classification of various tissue matrix, from the United States
Dear Ms. Wilkes:
In your letter dated October 17, 2017, you requested a tariff classification ruling. No samples were provided with your letter but in a follow-up email you stated these products will be imported as finished products for therapeutic use.
ALLODERM SELECT™ Regenerative Tissue Matrix is described as a donated allograft human dermis, processed to remove cells while preserving the essential biological components and structure of the dermal matrix. This tissue matrix is indicated to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. It is intended for single patient use only to support rapid revascularization, cell repopulation, and white cell migration offering surgeons a natural solution for soft tissue support where weakness exists.
Cymetra™ Micronized AlloDerm™ Tissue (CYMETRA™ MAT) is a micronized, particulate form of ALLODERM™ Tissue Matrix that contains the same key elements for tissue regeneration. It is a rigorously screened, individually tested, aseptically processed human tissue that incorporates rapidly with recipient tissue. CYMETRA™ MAT supports rapid revascularization, cell repopulation, and white cell migration. Surgeons can use it via injection for a variety of tissue graft procedures and correction of soft tissue defects such as injection laryngoplasty.
STRATTICE™ Reconstructive Tissue Matrix (STRATTICE ™ TM) is a surgical mesh that is derived from porcine skin and consists of a terminally sterilized sheet of processed porcine dermal matrix in prescribed geometric configurations and thickness packaged in a double pouch configuration. It is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use also include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. This tissue matrix is intended for single patient one-time use only and derived from a porcine source.
The applicable subheading for ALLODERM SELECT™ Regenerative Tissue Matrix, Cymetra™ Micronized AlloDerm™ Tissue and STRATTICE™ Reconstructive Tissue Matrix will be 3001.90.0190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Glands and other organs for organotherapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organotherapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included: 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 https://hts.usitc.gov/current.
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 Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division