Duns Number:808344183
Device Description: Contains: (1) Intracept Flexible Bi-Polar RF Probe and (1) Intracept Access Instruments - Contains: (1) Intracept Flexible Bi-Polar RF Probe and (1) Intracept Access Instruments - Trocar
Catalog Number
RLV PKTLR
Brand Name
Intracept
Version/Model Number
RLV PKTLR
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
0e0cd258-54e2-421b-b68a-47abf159d5b7
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 01, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |