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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laryngoscope kit
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 CodeOGH
Regulation Number 868.5540
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Image Orientation Incorrect 1 1
Difficult to Remove 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Flexicare Medical Ltd. II Jan-13-2020
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