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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orotracheal intubation guide 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 CodeOGK
Regulation Number 868.1400
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD Inc. II Sep-01-2021
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