# ACRA-CUT 11/7mm DGR-II Mini

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

- Canonical page: <https://devicerts.com/devices/acra-cut-200-253>
- Manufacturer: [Acra-Cut Inc](https://devicerts.com/manufacturers/acra-cut-inc) (United States)
- Device class: Class IIa (EU MDD); Class II (US FDA)
- FDA product code: HBF
- EMDN: P091304 CRANIAL PERFORATORS, SINGLE-USE
- GMDN: Automatic cranial perforator, single-use (46277)
- GMDN: Cranial trephine, single-use (46272)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-00810607000057 · UDI-DI 00810607000057 · registered 2026-11-06 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00810607000057 · listed 2016-09-23 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K833266 · decision 1983-12-29 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: ACRA-CUT [FDA GUDID (AccessGUDID)]; Disposable Cranial Perforator [FDA GUDID (AccessGUDID)]
- Generic name: Automatic cranial perforator, single-use [FDA GUDID (AccessGUDID)]; Cranial trephine, single-use [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 200-253 DGR-II [EUDAMED]; 200-253 [EUDAMED, FDA GUDID (AccessGUDID)]; 11/7mm DGR-II Mini [FDA GUDID (AccessGUDID)]; 200-253 11/7 mm [FDA GUDID (AccessGUDID)]; 200-253 DGR -II [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00810607000057 [EUDAMED, FDA GUDID (AccessGUDID)]; 00810607002532 [FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-00810607000057 [EUDAMED]
- 510(k) Number: K833266 [FDA GUDID (AccessGUDID)]
- FDA product code: HBF [FDA GUDID (AccessGUDID)]
- EMDN code: P091304 [EUDAMED]
- GMDN term: Automatic cranial perforator, single-use (46277) [FDA GUDID (AccessGUDID)]; Cranial trephine, single-use (46272) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 882.4305 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Radiation Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]; Yes [FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]; No [FDA GUDID (AccessGUDID)]
- Implantable: 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 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]
- Prescription use: 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)]

## Source and citation

- Cite as: ACRA-CUT 11/7mm DGR-II Mini, Acra-Cut Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/acra-cut-200-253 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/acra-cut-200-253.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/acra-cut-200-253
- 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.