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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ct biopsy tray
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 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 CodeOFG
Regulation Number 870.4075
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2021 1 1
2023 1 1
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Battery Problem 2 2
Device Sensing Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Crack 1 1
Material Fragmentation 1 1
Failure to Sense 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
3 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
5 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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