# 3-D Matrix, Inc. (manufacturer, Newton, MA): 4 new FDA device listings, incl. hemostatic device for endoscopic gastrointestinal use

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | 3-D Matrix, Inc. |
| Owner / operator | 3D-Matrix |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Newton, MA, US |
| New listings | 4 |
| Devices | Hemostatic Device For Endoscopic Gastrointestinal Use; Protective Coating, Mucoadhesive Application, For The Rectal Mucosa |
| Product codes | QAU, PHN |
| Device classes | Class II, Unclassified |
| Medical specialties | General, Plastic Surgery |
| Brand names | PuraStat |
| First new listing | 2026-05-07 |
| Latest new listing | 2026-08-14 |
| FDA registration number | 3015528146 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.