F14.Manufacturer postal code: d-79111.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).Biosense webster manufacturer's reference number (b)(4) has 2 reports.(1) manufacture report number # 2029046-2024-00670 for unknown thermocool smarttouch) (2) importer report number # 2029046-2024-50001 for the unknown ¿ system rf generator (us).
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