# iovera STT21180STIM-5

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

- Canonical page: <https://devicerts.com/devices/iovera-stt21180stim-5>
- 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: Hand-held cryosurgical system handpiece tip (60508)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00816287020323 · listed 2026-07-27 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K243677 · decision 2024-12-26 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: iovera [FDA GUDID (AccessGUDID)]
- Generic name: Hand-held cryosurgical system handpiece tip [FDA GUDID (AccessGUDID)]
- Model / reference: STT21180STIM-5 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00816287020323 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K243677 [FDA GUDID (AccessGUDID)]
- FDA product code: GXH [FDA GUDID (AccessGUDID)]
- GMDN term: Hand-held cryosurgical system handpiece tip (60508) [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)]

## Clinical & Handling

- Sterilisation method: Ethylene Oxide [FDA GUDID (AccessGUDID)]
- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: 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)]
- 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: iovera STT21180STIM-5, Pacira Pharmaceuticals, INC. deviCERTS medical device catalogue. https://devicerts.com/devices/iovera-stt21180stim-5 (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-stt21180stim-5.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-stt21180stim-5
- 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.