3-D MATRIX, INC.

FDA Device Registration & Listing · Newton, MA, US · Registration 3015528146

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015528146
FEI Number
3015528146
Entity Name
3-D MATRIX, INC.
City/State/Country
Newton, MA, US
Establishment Address
1234 Chestnut St., Suite 205, Newton, MA 02464, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
3D-Matrix (Owner Number: 10060325)
Owner / Operator Contact Address
1234 Chestnut St., Suite 205, Suite 205, Newton, MA 02464, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K213552
PMA Number
N/A

All Registered Proprietary Names

Syringe Adapter PuraStat PuraGel PuraSinus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2025-03-29
QAU Hemostatic Device For Endoscopic Gastrointestinal Use General, Plastic Surgery Class 2 878.4456 2026-05-07
QAU Hemostatic Device For Endoscopic Gastrointestinal Use General, Plastic Surgery Class 2 878.4456 2022-01-25
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat Class 2 874.3620 2019-04-25
PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa Unknown Class U N/A 2026-05-07

Official Correspondent

Alan Miskewicz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

3D-Matrix
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2025 Wilson-Cook Medical Inc. 2
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015528146. Last updated year: 2026. Please use registration number 3015528146 when referencing this establishment in official correspondence.
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