Duns Number:663190222
Device Description: Single-use RF Cannula
Catalog Number
-
Brand Name
LCCS
Version/Model Number
C-502-22-LC
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
K112231,K112231,K112231
Product Code
GXI
Product Code Name
Probe, Radiofrequency Lesion
Public Device Record Key
b28caf5a-f146-42c2-af69-869a6e9d2df6
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
July 24, 2021
Package DI Number
14895233601017
Quantity per Package
25
Contains DI Package
04895233601010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 46 |