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U.S. Department of Health and Human Services

Product Classification
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Device internal tissue marker
Regulation Description Internal tissue marker.
Definition An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.
Physical State Marker with dye.
Technical Method A biocompatible dye that is applied to the target tissue using a soft tipped marker.
Target Area Organs, veins, arteries and other internal tissues.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePDW
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4670
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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