Duns Number:079940465
Device Description: ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS AND (60) 2MM & 5 MM APPL ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS AND (60) 2MM & 5 MM APPLICATORS
Catalog Number
CRY25
Brand Name
ICEOUT™
Version/Model Number
CRY25
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
K152203
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
001bbeb3-d70d-4ea6-b077-81c9bc617445
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 17, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 433 |