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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, conduction, anesthesia, reprocessed
Regulation Description Anesthesia conduction needle.
Definition A reprocessed needle is a device used to inject local anesthesia into a patient to provide regional anesthesia. This is the same as "BSP." Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNNH
Regulation Number 868.5150
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1

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