# DEN130004: Moerae Surgical Marking Pen

- Pathway: De Novo (Post-NSE)
- Applicant: Moerae Matrix, Inc.
- Decided: Dec 18, 2014 after 591 days
- Product code: PDW (Internal Tissue Marker)
- Device class: 2
- Regulation: 21 CFR 878.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
use prior to or during the harvesting and preparation of vein grafts used in bypass surgery. The pen is used to demarcate selected sites and orientation of the graft

Source page: https://510kreport.com/device/DEN130004
Methodology: https://510kreport.com/methodology