Catalog Number

-

Brand Name

Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode

Version/Model Number

NIM05010BB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

6a6407e6-74ed-494f-abab-a72a9901d7fa

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

March 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-