# Phasor Drill 008-1049

> Listed: FDA GUDID listing, not in commercial distribution. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/phasor-drill-ph-240-210>
- Manufacturer: [Biotex, Inc.](https://devicerts.com/manufacturers/biotex-inc) (United States, FDA applicant)
- Device class: Class II (US FDA)
- FDA product code: HBE, KIJ, GFG
- GMDN: Craniotomy power tool system, battery-powered, single-use (46275)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI M710PH2402100 · listed 2019-12-06 · status: Listed (GUDID: not in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: Phasor Drill [FDA GUDID (AccessGUDID)]
- Generic name: Craniotomy power tool system, battery-powered, single-use [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 008-1049 [FDA GUDID (AccessGUDID)]; PH-240-210 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: M710PH2402100 [FDA GUDID (AccessGUDID)]
- FDA product code: HBE [FDA GUDID (AccessGUDID)]; KIJ [FDA GUDID (AccessGUDID)]; GFG [FDA GUDID (AccessGUDID)]
- GMDN term: Craniotomy power tool system, battery-powered, single-use (46275) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 882.4310 [FDA GUDID (AccessGUDID)]; 878.4820 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: Not in Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

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

## Dimensions & Sizes

- Size: Outer Diameter — 2.4 Millimeter [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)]
- Manufacturing 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)]

## Source and citation

- Cite as: Phasor Drill 008-1049, Biotex, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/phasor-drill-ph-240-210 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/phasor-drill-ph-240-210.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/phasor-drill-ph-240-210
- 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.
