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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
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

MDR Year MDR Reports MDR Events
2017 1 1
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Material Frayed 1 1
Labelling, Instructions for Use or Training Problem 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Avid Medical, Inc. II Mar-19-2020
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