# Ethicon Securestrap STRAP12R

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

- Canonical page: <https://devicerts.com/devices/ethicon-securestrap-strap12r>
- Manufacturer: [Ethicon Inc.](https://devicerts.com/manufacturers/ethicon-inc) (United States)
- Name in the registry: ETHICON SECURESTRAP STRAP12R
- Device class: Class III (EU MDR); Class II (US FDA)
- FDA product code: GDW
- EMDN: H020399 STAPLERS, VIDEOSURGERY - OTHER
- GMDN: Endoscopic manual linear stapler (59874)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 0705031a000073X · UDI-DI 10705031470576 · registered 2025-11-14 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 10705031470576 · listed 2024-04-05 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K093845 · decision 2010-04-07 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1260-2011 ·  · terminated · initiated 2010-12-29: The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.

## Identity

- Trade name: ETHICON SECURESTRAP [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Endoscopic manual linear stapler [FDA GUDID (AccessGUDID)]
- Device name: ETHICON SECURESTRAP Absorbable Strap Fixation Device [EUDAMED]
- Model / Ref / Catalog: STRAP12R [EUDAMED, FDA GUDID (AccessGUDID)]; ETHICON SECURESTRAP [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 10705031470576 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 0705031a000073X [EUDAMED]
- 510(k) Number: K093845 [FDA GUDID (AccessGUDID)]
- FDA product code: GDW [FDA GUDID (AccessGUDID)]
- EMDN code: H020399 [EUDAMED]
- GMDN term: Endoscopic manual linear stapler (59874) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class III [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4750 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Belgium [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Safe [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 CMR substances (carcinogenic, mutagenic or toxic to reproduction): 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]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal 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: Ethicon Securestrap STRAP12R, Ethicon Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/ethicon-securestrap-strap12r (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: 2026-11-07
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/ethicon-securestrap-strap12r.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/ethicon-securestrap-strap12r
- 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.