# PriMatrix® 607-005-440

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/primatrix-r-607-005-440>
- Manufacturer: [Tei Biosciences Inc.](https://devicerts.com/manufacturers/tei-biosciences-inc) (United States)
- Device class: Class III (EU MDD); Unclassified (US FDA)
- FDA product code: KGN
- EMDN: M0499 SPECIAL DRESSINGS - OTHER
- GMDN: Animal-derived wound matrix dressing (45023)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-10381780113447 · UDI-DI 10381780113447 · registered 2026-08-18 · status: Active
- **GUDID** · FDA 510(k) · United States · K153690 · decision 2016-02-22 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI 10381780113447 · listed 2015-10-21 · status: Listed (GUDID: in commercial distribution)

## Recalls

- Z-2078-2023 · Class II · ongoing · initiated 2023-05-23: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- Z-2077-2023 · Class II · ongoing · initiated 2023-05-23: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- Z-2079-2023 · Class II · ongoing · initiated 2023-05-23: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- Z-0383-2018 · Class II · terminated · initiated 2017-06-15: During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 IFUs were missing pages 27 - 50 " 1 IFU was missing pages 1 - 2 & 75 - 76 " 1 IFU was missing pages 15 - 62 While pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.

## Identity

- Trade name: PriMatrix® [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Animal-derived wound matrix dressing [FDA GUDID (AccessGUDID)]
- Device name: Dermal Repair Scaffold [EUDAMED]
- Model / Ref / Catalog: 607-005-440 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 10381780113447 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-10381780113447 [EUDAMED]
- 510(k) Number: K153690 [FDA GUDID (AccessGUDID)]
- FDA product code: KGN [FDA GUDID (AccessGUDID)]
- EMDN code: M0499 [EUDAMED]
- GMDN term: Animal-derived wound matrix dressing (45023) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class III [EUDAMED]; U [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Belgium [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Implantable: Yes [EUDAMED]; No [FDA GUDID (AccessGUDID)]
- Contains animal tissues or cells: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: PriMatrix® 607-005-440, Tei Biosciences Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/primatrix-r-607-005-440 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/primatrix-r-607-005-440.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/primatrix-r-607-005-440
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.