FDA.reportPublic FDA data

TargetCool

Primary DI
08800073100018
Brand
TargetCool
Company
RecensMedical, Inc.
Model
RM-DT02W
Device description
TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue.
Published
2021-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories
MLYVapocoolant Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2
MLYVapocoolant DeviceUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800073100018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800073100018088000731000188800073100018

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, mechanicalAn assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
694808508
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800073100124OcuCoolODM-E012026-05-19
08800073100148TargetCool-eRH-PD06W2026-05-14
08800073100049TargetCoolRM-DC04U2022-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450457382C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-07-20
10723797751388Hurri-Freeze HFO Topical Anesthetic SprayBEUTLICH PHARMACEUTICALS, LLCMLY2026-06-26
10723797751395Hurri-Freeze HFO Topical Anesthetic SprayBEUTLICH PHARMACEUTICALS, LLCMLY2026-06-26
00884450457511C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457528C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457566C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457573C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
10723797170615InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170721InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170837InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170943InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
10723797806446Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797807443Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797809447Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
00860010587355DentalJect ApplicatorVapocoolshot, IncMLY2025-11-07
00860010587362DentalJect Syringe ConnectorVapocoolshot, IncMLY2025-11-07
00860010587393DentalJect Starter Kit - No Syringe ConnectorVapocoolshot, IncMLY2025-11-07
10888853004836Freeze Away Pinpoint Skin Tag RemoverSCHOLL'S WELLNESS COMPANY LLCGEH2025-10-01