# PriMatrix Ag 607-101-112

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

- Canonical page: <https://devicerts.com/devices/primatrix-ag-607-101-112>
- Manufacturer: [Tei Biosciences Inc.](https://devicerts.com/manufacturers/tei-biosciences-inc) (United States)
- Device class: Unclassified (US FDA)
- FDA product code: FRO
- GMDN: Animal-derived wound matrix dressing (45023)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 10381780113492 · listed 2015-10-14 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K100261 · decision 2010-12-10 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2082-2023 · Class II · ongoing · initiated 2023-05-23 · matched through shared submission K100261, may concern other models: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- Z-2081-2023 · Class II · ongoing · initiated 2023-05-23 · matched through shared submission K100261, may concern other models: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- Z-2080-2023 · Class II · ongoing · initiated 2023-05-23 · matched through shared submission K100261, may concern other models: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

## Identity

- Trade name: PriMatrix Ag [FDA GUDID (AccessGUDID)]
- Generic name: Animal-derived wound matrix dressing [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 607-101-112 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 10381780113492 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K100261 [FDA GUDID (AccessGUDID)]
- FDA product code: FRO [FDA GUDID (AccessGUDID)]
- GMDN term: Animal-derived wound matrix dressing (45023) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: U [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Safe [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- 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 Ag 607-101-112, Tei Biosciences Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/primatrix-ag-607-101-112 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [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-ag-607-101-112.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-ag-607-101-112
- 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.