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Sign in to claim this brand3-D Matrix, Inc.
US
Last updated September 17, 2026
What 3-D Matrix, Inc. makes
3-D Matrix, Inc. manufactures biodegradable intranasal splints and haemostatic agents, including synthetic peptide-based formulations. Their portfolio includes products designed to control bleeding in surgical and trauma settings, as well as nasal procedures, with variations in delivery forms such as gels and liquids. Examples include intranasal splints for sinus applications and haemostatic agents for gastrointestinal and general surgical use.
The company’s devices are classified under FDA categories Class II and Unclassified (U), with regulatory submissions including 510(k) clearances and UDI listings. These products are authorised for use in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does 3-D Matrix, Inc. manufacture?
3-D Matrix, Inc. specializes in two primary categories of medical devices: biodegradable intranasal splints, which are used to support nasal structures during procedures like sinus surgery, and haemostatic agents designed to control bleeding. Their haemostatic portfolio includes both non-organic and synthetic peptide-based formulations, such as gels and liquids, tailored for surgical and trauma settings. Examples include products like PuraStat for general surgical bleeding and PuraSinus for nasal applications.
Where is 3-D Matrix, Inc. based, and where are their devices authorised for use?
3-D Matrix, Inc. is headquartered in the United States. Their devices are authorised for use in the US, where they undergo regulatory review by the FDA. The company’s portfolio includes products that have been cleared through pathways like the 510(k) process and are listed in the FDA’s Unique Device Identification (UDI) system.
How are the devices manufactured by 3-D Matrix, Inc. classified by the FDA?
The devices produced by 3-D Matrix, Inc. fall under two FDA classification categories: Class II and Unclassified (U). Class II devices generally require special controls to ensure their safety and effectiveness, while Unclassified devices may require additional review or have unique regulatory pathways depending on their risk profile. The classification helps determine the regulatory pathway for authorisation, such as 510(k) clearance or other submissions.
Which regulatory registries or databases list the devices made by 3-D Matrix, Inc.?
The devices manufactured by 3-D Matrix, Inc. are listed in the FDA’s 510(k) clearance registry and the Unique Device Identifier (UDI) database. These registries track authorised medical devices in the US, including their clearance pathways and identification details, ensuring transparency and traceability for healthcare providers and regulators.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1234 Chestnut St., Newton, MA, 02464
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3015528146
- DUNS Number
- 058207695
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PuraStat (3mL) | 621-062 | FDA UDI | Class II | Active |
| PuraGel 3mL | 651-005 | FDA UDI | Class II | Active |
| PuraGel 1mL | 651-004 | FDA UDI | Class II | Unknown |
| PuraSinus 5mL | 651-009 | FDA UDI | Class II | Active |
| PuraSinus 3mL | 651-008 | FDA UDI | Class II | Active |
| PuraGel 5mL | 651-006 | FDA UDI | Class II | Active |
| PuraSinus 1mL | 651-007 | FDA UDI | Class II | Active |
| PuraStat (1mL) | 621-061 | FDA UDI | Class II | Active |
| PuraStat-GI | K210098 | FDA 510(k) | Class II | Active |
| PuraStat-RM | K213552 | FDA 510(k) | U | Active |
| PuraStat | K222481 | FDA 510(k) | Class II | Active |
| PuraDerm Gel | K143058 | FDA 510(k) | U | Active |
| PuraStat-OM | K210211 | FDA 510(k) | U | Active |
| PuraDERM Gel | K193085 | FDA 510(k) | U | Active |
| PuraSinus | K183015 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
3-D Matrix, Inc. has one FDA recall record initiated on December 2, 2019, which is listed with a terminated status. The reason stated for the recall was that the boxes used by the shipper were not validated for use during transport.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 2, 2019 | Z-0744-2022 | — | terminated | The boxes used by the shipper were not validated for use during transport. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- 3-D Matrix, Ltd. Chiyoda-ku Tokyo · JP FEI 3007162658