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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

MDR Year MDR Reports MDR Events
2016 1 1
2017 1 1
2019 2 2

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

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