Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007162658

FEI Number

3007162658

Entity Name

3-D MATRIX, LTD.

City/State/Country

Chiyoda-ku Tokyo, JP

Establishment Address

Frontier Kojimachi Building 7F, Kojimachi 3-2-4, Chiyoda-ku Tokyo 102-0083, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

3-D Matrix, Ltd. (Owner Number: 10061211)

Owner / Operator Contact Address

Frontier Kojimachi Building 7F, Kojimachi 3-2-4, Chiyoda-ku, JP-13 102-0083, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210098

PMA Number

N/A

All Registered Proprietary Names

PuraGel Syringe Adapter PuraStat

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2019-09-17
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2025-04-17
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	General, Plastic Surgery	Class 2	878.4456	2022-02-02

Official Correspondent

Eri Kurita

US Agent Details

Alan Miskewicz Business: 3D-Matrix Email: amiskewicz@3dmatrix.com Phone: (781) 3739020

Related Public Records

Same Entity

3-D Matrix, Ltd.

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.

Similar Registrations

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3012448339	STERI-TEK	Fremont, CA, US
1058584	Sterigenics US LLC	Charlotte, NC, US
1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007162658. Last updated year: 2026. Please use registration number 3007162658 when referencing this establishment in official correspondence.