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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device custom anesthesia tray
Regulation Description Anesthesia conduction catheter.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Product CodeOGD
Regulation Number 868.5120
Device Class 2

Recalls
Manufacturer Recall Class Date Posted
1 Avid Medical, Inc. II Mar-19-2020
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
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