Duns Number:006133784
Device Description: cryoICE cryoFORM 10 cm Corrugated Stainless Steel Cryoablation Probe
Catalog Number
A000957-2
Brand Name
cryoICE Cryoablation System
Version/Model Number
CRYOF
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"
Yes
For Single-Use
Yes
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
K180137
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
04652e27-7233-44c6-b265-fd5fb9824330
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
April 01, 2018
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 | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |
| 3 | A medical device with high risk that requires premarket approval | 11 |