TargetCool (RM-DT02W)

No FDA recalls found in the data synced 23 Oct 2026.

Full name

TargetCool

Generic Name

General cryosurgical system, cryogen gas, mechanical

Model / Reference

RM-DT02W, UM-001-CV

Primary DI / UDI-DI

08800073100018

Basic UDI-DI

88000731RM-DT02WJP, B-08800073100018

FDA Product Code

GEH, MLY

EMDN Code

M9001, Z120102

GMDN Term

General cryosurgical system, cryogen gas, mechanical

Device Class

Class IIa EUDAMED

Class II GUDID

Regulation Number

878.4350

EU market of registration

Italy

GUDID distribution status

In Commercial Distribution

EUDAMED SRN

KR-MF-000013578

Authorised representative

CMC Medical Devices & Drugs SL ES-AR-000000293

Category: Hot/cold therapy pack, reusable

• TargetCool-e RH-PD06W

  Class II

  CE/MDR 2025-MDR/QS-057/B Active Valid to Nov 2030 GUDID on market

• OcuCool ODM-E01

  Not classified

  GUDID on market

• OcuCool

  Not classified

  FDA De Novo DEN230011 Active Cleared 30 Sep 2024 FDA 510(k)

• CryoVIVE

  Class II

  FDA 510(k) K203481 Active Cleared 13 May 2021

• What types of medical procedures is the TargetCool designed to support, and why is it specifically categorized under nomenclature code M9001?

  The TargetCool is designed for controlled freezing of tissue, commonly used in procedures like skin lesion removal, tumor ablation, and cosmetic treatments in general and plastic surgery. It falls under nomenclature code M9001 because this classification specifically identifies it as a **Cryosurgical Unit and Accessories**, which aligns with its function of delivering precise cryotherapy through localized cooling.

• Is the TargetCool reusable or single-use, and what does this mean for clinical workflows?

  The TargetCool is explicitly designed for **single-use applications only** and is not intended for reprocessing or reuse. This means each device must be discarded after one use, ensuring patient safety and compliance with regulatory standards. Clinicians should plan accordingly to avoid cross-contamination and maintain proper inventory management.

• How should the TargetCool be stored, and what considerations should be taken into account given its non-sterile status?

  Since the TargetCool is **non-sterile**, it must be stored in a clean, dry environment as a medical instrument, following manufacturer guidelines to prevent contamination. It should not be exposed to extreme temperatures or moisture, and storage conditions should align with standard medical device protocols to preserve functionality and compliance with regulatory requirements.

• What regulatory pathways does the TargetCool follow, and how does this impact its availability in different markets?

  The TargetCool has undergone **FDA 510(k) clearance (K220674)**, as well as compliance with the **MDD (Medical Device Directive)** and **MDR (Medical Device Regulation)**. This means it is legally marketed in the U.S. under FDA standards and in the EU under MDR compliance, ensuring traceability via its **UDI (88000731RM-DT02WJP)**. Buyers should verify local regulatory requirements before procurement.

• What model does the TargetCool come in, and are there variations or accessories included in the supply?

  The TargetCool is supplied as a single model, **RM-DT02W**, and operates as a **Cryosurgical Unit with accessories** for localized tissue freezing. While the exact accessory configurations are not detailed, the device is designed to work with compatible cryoprobes or applicators for targeted procedures. Always refer to the manufacturer’s instructions for specific accessory compatibility.