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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device seal, cervical, mechanical, unpowered
Definition Reduce fluid leakage from the cervix during hysteroscopic procedures.
Product CodeQHZ
Regulation Number 884.1690
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2 2
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1

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

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