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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device specula accessories
Product CodeFXG
Regulation Number 878.1800
Device Class 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Apr-11-2022
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