Duns Number:038024868
Device Description: The CryOmega is a disposable device intended for the surgical destruction of target tissue 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.
Catalog Number
160-2002
Brand Name
CryOmega
Version/Model Number
160-2002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K102006,K102006
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
c7642614-4102-4bbf-beec-e279752ab7ae
Public Version Date
February 04, 2020
Public Version Number
1
DI Record Publish Date
January 27, 2020
Package DI Number
10850077006217
Quantity per Package
5
Contains DI Package
00850077006210
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Twin Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |