Duns Number:006133784
Device Description: Coolrail Linear Pen, 30 mm linear electrode
Catalog Number
A000475
Brand Name
Isolator Surgical Ablation System
Version/Model Number
MCR1
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
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
-
Product Code
OCL
Product Code Name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Public Device Record Key
8123777b-477b-4993-bca8-573d7c57fac9
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 11, 2021
Package DI Number
30840143902455
Quantity per Package
1
Contains DI Package
10840143902253
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 |