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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hysterectomy 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 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 CodeOJF
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2019 1 1
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 2 2
Device Damaged Prior to Use 1 1
Device Contamination With Biological Material 1 1
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Break 1 1
Fire 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Jan-26-2024
2 American Contract Systems, Inc. II Oct-26-2023
3 Customed, Inc I Dec-16-2014
4 Customed, Inc I Aug-29-2014
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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