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

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
10850077006002PackageGS110In Commercial Distribution
00850077006005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007700600210850077006002
00850077006005008500770060058500770060050850077006005

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
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
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#

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
00850077006210CryOmega160-2002160-20022020-01-27
00850077006067CryoLab Medical200-1000200-10002019-07-15
00850077006074CryoLab Aesthetics700-1000700-10002019-07-03
00850077006005CryOmega160-2001160-20012016-09-24

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