FDA.reportPublic FDA data

CryOmega

Primary DI
00850077006210
Brand
CryOmega
Company
CRYOCONCEPTS, LP
Model
160-2002
Catalog number
160-2002
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 of lesions that can be treated:• Actinic Keratosis• Genital Lesions• Lentigo• Molluscum Contagiosum• Seborrheic Keratoses• Skin Tags• Verruca Plana• Verruca Plantaris• Verruca VulgarisAngiomas• Acne (Cysts & Scars)• Scars (Keloids)• Angiomas• Spider Angiomas• Teleangiectases• Keratosis Pilaris (Milia)• Sebaceous HyperplasiaThe CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
Published
2020-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102006000CRYOMEGAStc Consulting, LLC2010-10-06GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850077006217PackageGS15In Commercial Distribution
00850077006210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007700621710850077006217
00850077006210008500770062108500770062100850077006210

GMDN Terms#

Term, Definition table
TermDefinition
Cryogenic spray, cutaneousA 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
TypeValueUnit
Weight16Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Protect device from sunlight.
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-355-2796support@cryoconcepts.com

Regulatory Flags#

DUNS number
038024868
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850077006081Histofreezer1001-029340T1C2020-09-22
00850077006098Histofreezer1001-029436F1C2020-06-24
00850077006104Histofreezer1001-029536M1C2020-09-22
00850077006111Histofreezer1001-03365M1C2020-09-22
00850077006340Histofreezer FLEX200-305050SB2020-09-13
00850077006357Histofreezer FLEX200-405150SC2020-09-13
00850077006364Histofreezer FLEX200-505250SM2020-09-13
00850077006128Histofreezer1001-037560MC2 + 102020-09-22
00850077006371Histofreezer FLEX200-608080SM2020-09-13
10850077006088Histofreezer1001-029340T1C2020-09-22
10850077006101Histofreezer1001-029536M1C2020-09-22
10850077006118Histofreezer1001-03365M1C2020-09-22
00850077006388Histofreezer FLEX200-305050SB2020-09-13
00850077006395Histofreezer FLEX200-405150SC2020-09-13
00850077006401Histofreezer FLEX200-505250SM2020-09-13
10850077006095Histofreezer1001-029436F1C2020-06-24
00850077006067CryoLab Medical200-1000200-10002019-07-15
00850077006074CryoLab Aesthetics700-1000700-10002019-07-03
00850077006005CryOmega160-2001160-20012016-09-24
00850077006036CryOmega800-2001800-20012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
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