Duns Number:824951958
Device Description: RF Cannula, 10cm,10mm active tip, Sharp, 20 gauge, siliconized
Catalog Number
-
Brand Name
NA
Version/Model Number
CC101020VZ
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
GXI
Product Code Name
PROBE, RADIOFREQUENCY LESION
Public Device Record Key
5a50571b-8e1a-4be1-a6ab-1c2677938f58
Public Version Date
October 08, 2018
Public Version Number
3
DI Record Publish Date
June 29, 2017
Package DI Number
00813250018059
Quantity per Package
10
Contains DI Package
00813250018042
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 248 |
| 3 | A medical device with high risk that requires premarket approval | 442 |