OT:RR:NC:N3:135
Shivali Puri
Integra LifeSciences
1100 Campus Road
Princeton, NJ 08540
RE: The country of origin of Halstead Mosquito Forceps
Dear Ms. Puri:
In your letter dated April 28, 2025, you requested a country of origin ruling on Halstead Mosquito Forceps.
Additional information was provided via email dated April 29, 2025.
The Halstead Mosquito Forceps are small, straight, or curved instruments featuring fine, serrated jaws
designed to securely hold and compress tissue and blood vessels. They are a type of surgical
instrument primarily used to clamp blood vessels during delicate medical procedures in general surgery,
dentistry, veterinary procedures and other medical disciplines requiring precise control of small vessels or
other anatomical structures.
Raw stainless steel is sourced from Germany and shipped to the United States. In the United States, the
stainless steel is hot forged using a die and drop hammer to impart the final form and distinctive anatomical
features of the forceps, including jaws, handles, and the hinge area. After forging, the part is annealed to
relieve internal stresses and prepare it for subsequent refinement. You state at this stage the product has taken
on its distinctive shape and is clearly identifiable as a medical instrument. In Pakistan, the following finishing
and assembly operations are performed: minor excess material is removed (“flash”) from edges of the
forging, machining and milling of serrations, box and rachet, insertion of boxlock pins, filing, heat treating,
polishing, electropolishing, passivation, riveting, and final surface preparation. Next, the forceps are sent to
Germany for final inspection, labelling, and packing before being exported to the United States.
When determining the country of origin, the substantial transformation analysis is applicable. See, e.g.,
Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a
substantial transformation will occur is whether an article emerges from a process with a new name,
character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v.
United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See
National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).
In our opinion, the US operations, hot forging including drop hammering, and annealing, taken together
transform the German raw stainless steel into a new product with changes in name, character, and use. This
process in the United States gives the forceps the distinctive shape, character, and use, and results in a
substantial transformation. The remaining operations in Pakistan are finishing and simple assembly
operations and do not alter the overall shape, character, or use of the product. Accordingly, the country of
origin of the Halstead Mosquito Forceps will be the United States.
If a good is determined to be an article of U.S. origin, it is not subject to the country of origin marking
requirements of 19 U.S.C. ?1304. ?Whether an article may be marked with the phrase ?Made in the USA? or
similar words denoting U.S. origin, is an issue under the authority of the Federal Trade Commission
(FTC). We suggest that you contact the FTC Division of Enforcement, 600 Pennsylvania Avenue, N.W.,
Washington, D.C. 20580 on the propriety of proposed markings indicating that an article is made in the USA.
You state that other surgical instruments such as surgical scissors, clamps, and additional types of forceps are
produced using the same bi-national manufacturing process. As such, you believe the determination made in
connection with the Forceps may also, by analogy, be instructive and applicable to other medical instruments
manufactured under identical conditions. Substantial transformation determinations are based on the totality
of the evidence. See Headquarters Ruling (HQ) W968434, date January 17, 2007, citing Ferrostaal Metals
Corp. v. United States, 11 CIT 470, 478, 664 F. Supp. 535, 541 (1987). The issue of whether a substantial
transformation occurs is determined on a case by case basis. See HQ 561353, dated September 19, 2002. If
you would like to request a country of origin ruling for other surgical instruments, please send a new ruling
request.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
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, please contact
National Import Specialist Fei Chen at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division