# iovera IST2221

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

- Canonical page: <https://devicerts.com/devices/iovera-ist2221>
- Manufacturer: [Pacira Pharmaceuticals, INC](https://devicerts.com/manufacturers/fda-fei-3002783962) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: GXH
- GMDN: General cryosurgical system, cryogen gas, electronic (45738)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00816287020248 · listed 2023-06-13 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K211334 · decision 2021-09-10 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: iovera [FDA GUDID (AccessGUDID)]
- Generic name: General cryosurgical system, cryogen gas, electronic [FDA GUDID (AccessGUDID)]
- Model / reference: IST2221 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00816287020248 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K211334 [FDA GUDID (AccessGUDID)]
- FDA product code: GXH [FDA GUDID (AccessGUDID)]
- GMDN term: General cryosurgical system, cryogen gas, electronic (45738) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 882.4250 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

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

## Source and citation

- Cite as: iovera IST2221, Pacira Pharmaceuticals, INC. deviCERTS medical device catalogue. https://devicerts.com/devices/iovera-ist2221 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/iovera-ist2221.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/iovera-ist2221
- 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.