CLA-2-30:OT:RR:NC:N1:138
Mr. Mark Andrew Sclafani
Nissin International Transport USA, Inc.
172-47 Baisley Blvd.
Jamaica, NY 11570
RE: The tariff classification of Neoveil™ (suture and staple line reinforcement materials) from Japan
Dear Mr. Sclafani:
In your letter dated July 2, 2018, on behalf of Gunze International USA, Inc., you requested a tariff classification ruling. Your submission includes two samples packed in silver packets which will be retained by this office for reference only.
Neoveil is a sterile surgical mesh which is used as a suture and staple line reinforcement. It is a single use prescription only product that is composed of 100% bio-absorbable polyglycolic acid (PGA) available in a variety of sizes. Neoveil is indicated for use in surgical procedures in which the soft tissue transection or resection with staple or suture line reinforcement is needed. Neoveil can be used for suture or staple lines during lung resection, liver resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures. There are two types of Neoveil and both types are manufactured using the same biodegradable Polyglycolic Acid (PGA), which is degraded via a combination of hydrolytic and enzymatic pathways.
The first type is a “Tube type” (product code NV-ET-M60A-2) which consists of pre-formed porous bio-absorbable nonwoven sheets and is intended for use as a staple line reinforcement during surgical procedures. It is provided in the form of a sleeve. After deployment of the tube type reinforcement material, the non-degradable elastic knit, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. This tube type is indicated as reinforcement in stapled region of weak organs such as the lung, bronchi, liver and digestive tract. It also serves to reduce and prevent air leakage from the lung.
The second type is the “Sheet Type” (product code is NV-L-015G) which is a porous fibrous bio- absorbable sheet which is intended for a suture line reinforcement. It is a soft non-woven fabric with elasticity through a special process. It is colored with green dyestuff so it is easy to distinguish between Neoveil and tissues. This sheet type is indicated for reinforcement in sutured region of weak organs such as the lung, bronchi, liver and digestive tract. It also serves to reduce and prevent air leakage from the lung.
The applicable subheading for the Neoveil (suture and staple line reinforcement materials) will be 3005.90.5090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes: Other: 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 the 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