Duns Number:317654283
Device Description: RFTL 20G x 145mm, stimulatio RFTL 20G x 145mm, stimulation tip 5mm, grinding 15°,
Catalog Number
001165-30BM
Brand Name
RFTL
Version/Model Number
001165-30BM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 15, 2025
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
GXI
Product Code Name
PROBE, RADIOFREQUENCY LESION
Public Device Record Key
d8c2a444-f5d7-463e-983f-0ec032ed7545
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 01, 2016
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 979 |