Duns Number:006133784
Device Description: cryoICE Cryoablation System Cryo Module
Catalog Number
A00898-3
Brand Name
cryoICE Cryoablation System
Version/Model Number
ACM1
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
-
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
-
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
0be08e2a-3d25-48ed-abd8-7042f2089c80
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
January 11, 2021
Package DI Number
30840143900413
Quantity per Package
1
Contains DI Package
10840143900426
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| 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 |