# CL8903

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

- Canonical page: <https://devicerts.com/devices/n-a-cl8903>
- Manufacturer: [Medtronic PS Medical](https://devicerts.com/manufacturers/medtronic-ps-medical) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: HBO
- GMDN: Scalp wound clip (46953)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00721902371592 · listed 2020-09-12 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K050044 · decision 2005-02-07 · decision SESE · status: Active · from GUDID

## Recalls

- Z-3212-2018 · Class II · terminated · initiated 2018-05-03: The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.
- Z-0622-2018 · Class II · terminated · initiated 2017-12-20: Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

## Identity

- Generic name: Scalp wound clip [FDA GUDID (AccessGUDID)]
- Model / reference: CL8903 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00721902371592 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K050044 [FDA GUDID (AccessGUDID)]
- FDA product code: HBO [FDA GUDID (AccessGUDID)]
- GMDN term: Scalp wound clip (46953) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 882.4150 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [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)]
- 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)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: CL8903, Medtronic PS Medical. deviCERTS medical device catalogue. https://devicerts.com/devices/n-a-cl8903 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/n-a-cl8903.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/n-a-cl8903
- 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.