# Ace 00320101

> Listed: FDA GUDID listing, no authorization on record. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/ace-00320101>
- Manufacturer: [Ace Surgical Supply Co., Inc.](https://devicerts.com/manufacturers/ace-surgical-supply-co-inc) (United States, FDA applicant)
- Name in the registry: ACE 00320101
- Device class: Class I (US FDA)
- FDA product code: LXH
- GMDN: Surgical instrument guard, single-use, sterile (46505)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00614950012404 · listed 2019-10-13 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: ACE [FDA GUDID (AccessGUDID)]
- Generic name: Surgical instrument guard, single-use, sterile [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 00320101 [FDA GUDID (AccessGUDID)]
- Description: BUR GUARD MEDIUM STAINLESS STEEL 1-3/4" 4.5CM L/F [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00614950012404 [FDA GUDID (AccessGUDID)]
- FDA product code: LXH [FDA GUDID (AccessGUDID)]
- GMDN term: Surgical instrument guard, single-use, sterile (46505) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 888.4540 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]

## Dimensions & Sizes

- Size: Length — 4.5 Centimeter [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Single 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)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Ace 00320101, Ace Surgical Supply Co., Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/ace-00320101 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/ace-00320101.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/ace-00320101
- 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.