Home GUDID 10850077006002
CryOmega
Primary DI 10850077006002
Brand CryOmega
Company CRYOCONCEPTS, LP
Model 160-2001
Catalog number 160-2001
Device description The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated: • Genital Lesions • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana • Actinic Keratosis • Lentigo • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia. The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
Published 2016-09-24
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 Code Name GEH Unit, Cryosurgical, Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEH Unit, Cryosurgical, Accessories General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850077006002 Package GS1 10 In Commercial Distribution 00850077006005 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850077006002 10850077006002 00850077006005 00850077006005 850077006005 0850077006005
GMDN Terms# Term, Definition table Term Definition Cryogenic spray, cutaneous A refrigerant (e.g., dimethyl ether and propane) typically contained in an aerosol dispenser and intended to be used to freeze superficial skin lesions (e.g., warts) for their destruction and removal. After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Weight 16 Gram
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 038024868 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00884450457511 C2 CryoBalloon™ Merit Medical Systems, Inc. GEH 2026-06-02 00884450457528 C2 CryoBalloon™ Merit Medical Systems, Inc. GEH 2026-06-02 00884450457566 C2 CryoBalloon™ Merit Medical Systems, Inc. GEH 2026-06-02 00884450457573 C2 CryoBalloon™ Merit Medical Systems, Inc. GEH 2026-06-02 10840143902666 cryoICE® System ATRICURE, INC. GEH 2026-05-27 10840143902673 cryoICE® System ATRICURE, INC. GEH 2026-05-27 10840143902680 cryoICE® System ATRICURE, INC. GEH 2026-05-27 10840143902697 cryoICE® System ATRICURE, INC. GEH 2026-05-27 10840143902703 cryoICE® System ATRICURE, INC. GEH 2026-05-27 10840143902710 cryoICE® System ATRICURE, INC. GEH 2026-05-27 10840143902727 cryoICE® System ATRICURE, INC. GEH 2026-05-27 10840143902734 cryoICE® System ATRICURE, INC. GEH 2026-05-27 30840143904343 cryoICE® System ATRICURE, INC. GEH 2026-05-27 30840143912164 AtriCure® cryoICE® BOX ATRICURE, INC. GEH 2026-05-27 04050147024694 Erbe Erbe Elektromedizin GmbH GEH 2026-05-26 08800073100148 TargetCool-e RecensMedical, Inc. GEH 2026-05-14 06974083413115 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-23 06974083413122 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-23 06974083413313 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-23 06974083413320 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-23 06974083413337 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-23 06974083413412 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-23 06974083413528 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-23 06974083413221 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-22 06974083410718 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-01 06974083413214 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-01 06974083413511 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-01 06974083413818 CryoThin Medinux (Tianjin) Technologies Co., Ltd. GEH 2026-04-01 00860009734814 Artemis Eigen Health Services LLC GEH 2026-01-28 00860009734821 Artemis-TPOS Eigen Health Services LLC GEH 2026-01-28