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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture kit
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOVN
Regulation Number 878.4830
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 1 1
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Detachment of Device or Device Component 3 3
Product Quality Problem 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5 5
No Clinical Signs, Symptoms or Conditions 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
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