CryOmega 160-2002

GUDID 00850077006210

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 Hyperplasia The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.

CRYOCONCEPTS, LP

Cryogenic spray, cutaneous
Primary Device ID00850077006210
NIH Device Record Keyc7642614-4102-4bbf-beec-e279752ab7ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryOmega
Version Model Number160-2002
Catalog Number160-2002
Company DUNS038024868
Company NameCRYOCONCEPTS, LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-355-2796
Emailsupport@cryoconcepts.com

Device Dimensions

Weight16 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect device from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850077006210 [Primary]
GS110850077006217 [Package]
Package: Twin Pack [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-04
Device Publish Date2020-01-27

On-Brand Devices [CryOmega]

10850077006033The CryOmega is a disposable device intended for the surgical destruction of target tissue by ap
10850077006002The CryOmega is a disposable device intended for the surgical destruction of target tissue by ap
00850077006210The CryOmega is a disposable device intended for the surgical destruction of target tissue by ap

Trademark Results [CryOmega]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CRYOMEGA
CRYOMEGA
86412870 4847528 Live/Registered
CryoConcepts LP
2014-10-02
CRYOMEGA
CRYOMEGA
85099719 3979568 Live/Registered
CRYOCONCEPTS LP
2010-08-04

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