Catalog Number

-

Brand Name

Nimbus

Version/Model Number

NIM-050-10BB

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

K121773,K121773

Product Code

GXI

Product Code Name

Probe, Radiofrequency Lesion

Public Device Record Key

5a042def-2383-4747-8529-d7f8317723e7

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Package DI Number

10850040767039

Quantity per Package

10

Contains DI Package

00850040767032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-