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N2882632017-08-04New YorkClassification; Marking

The tariff classification and country of origin marking for “Spinal Treatments Kits” from Ireland

U.S. Customs and Border Protection · CROSS Database · 1 HTS code referenced

Cross-Source Intelligence

Data compiled from CBP CROSS Rulings, Census Bureau Trade Data · As of 2026-04-28 · Updates monthly

Summary

The tariff classification and country of origin marking for “Spinal Treatments Kits” from Ireland

Ruling Text

N288263 August 4, 2017 CLA-2-90:OT:RR:NC:2:235 CATEGORY: Classification; Marking TARIFF NO.: 9018.90.8000 Mr. David Lewis Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, Utah 84095 RE: The tariff classification and country of origin marking for “Spinal Treatments Kits” from Ireland Dear Mr. Lewis: In your letter dated July 10, 2017, you requested a tariff classification and country of origin marking ruling for “Spinal Treatments Kits.” In your submission, you have described the products at issue as vertebral augmentation system kits, which have been assembled, sterilized, and packaged in Ireland, at Merit’s Galway, Ireland facility. The “Spinal Treatments Kits” are comprised of various components, which are individually packaged, marked with the respective country of origin, and placed into a larger “kit box” for importation into the United States. The “Spinal Treatment Kits” are intended to treat pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. The applicable subheading for the “Spinal Treatments Kits” will be 9018.90.8000, 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: Other: Other: Other The general 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. You also requested a ruling on country of origin marking for the products at issue. The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. As provided in section 134.41(b), Customs Regulations (19 CFR 134.41(b)), the country of origin marking is considered conspicuous if the ultimate purchaser in the U.S. is able to find the marking easily and read it without strain. With regard to the permanency of a marking, section 134.41(a), Customs Regulations (19 CFR 134.41(a)), provides that as a general rule, marking requirements are best met by marking worked into the article at the time of manufacture. For example, it is suggested that the country of origin on metal articles be die sunk, molded in, or etched. However, section 134.44, Customs Regulations (19 CFR 134.44), generally provides that any marking that is sufficiently permanent so that it will remain on the article until it reaches the ultimate purchaser unless deliberately removed is acceptable. In your submission, you state that the kits are comprised of components from Costa Rica, Hungary, and Italy. You have offered two marking scenarios. In your preferred first scenario, you suggest leaving the kit box blank. You claim that the final purchaser will be able to ascertain the country of origin for each component upon opening the Spinal Kit box and its various component boxes because each component is marked with the country of origin. However, such a scenario defeats the purpose of the marking, since country of origin would not be revealed to the purchaser until after purchase. The second marking scenario you suggest would enable the final purchaser to ascertain the country of origin before purchase. Therefore, in accordance with the marking requirements of 19 U.S.C. 1304 and 19 CFR Part 134, the outermost container of the “Spinal Treatments Kits” should be marked as you have suggested in “Alternate # 2” below: “Alternative #2” – Have each of the components within the outer carton individually marked with their respective country of origin and mark the outer carton with a label that reads: “Assembled in Ireland with components from: AE Cable: Made in Costa Rica Activation Element: Made in Hungary Delivery Cannula: Made in Costa Rica ER Bone Cement: Made in Italy Hand Switch Cable: Made in Costa Rica Hydraulic Master Syringe Assemble: Made in Costa Rica Introducer: Made in Costa Rica Midline Osteotome: Made in Costa Rica” Note that if the name of a United States locality appears on the retail packaging, then the marking above must appear in close proximity and in letters of approximately the same size or larger. 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 Nuccio Fera at nuccio.fera@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division