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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tray, biopsy, without biopsy instruments
Regulation Description Manual gastroenterology-urology surgical instrument and accessories.
Product CodeFCH
Regulation Number 876.4730
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Defective Device 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Custom Medical Specialties, Inc. II Feb-22-2017
2 Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables II Dec-22-2016
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