# miraDry MD4000-BT

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

- Canonical page: <https://devicerts.com/devices/miradry-752dc4fb>
- Manufacturer: [miraDry Inc.](https://devicerts.com/manufacturers/miradry-inc) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: MWY, NEY, OUB
- GMDN: Electrosurgical system generator (11490)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00853419006022 · listed 2016-09-30 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: miraDry [FDA GUDID (AccessGUDID)]
- Generic name: Electrosurgical system generator [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: MD4000-BT [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00853419006022 [FDA GUDID (AccessGUDID)]
- FDA product code: MWY [FDA GUDID (AccessGUDID)]; NEY [FDA GUDID (AccessGUDID)]; OUB [FDA GUDID (AccessGUDID)]
- GMDN term: Electrosurgical system generator (11490) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4400 [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)]
- Expiration 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)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: miraDry MD4000-BT, miraDry Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/miradry-752dc4fb (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-11-08
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/miradry-752dc4fb.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/miradry-752dc4fb
- 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.