Catalog Number

-

Brand Name

Nimbus Probe (Disposable)

Version/Model Number

NDP-150-27-SS

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

K090608,K090608

Product Code

GXI

Product Code Name

Probe, Radiofrequency Lesion

Public Device Record Key

1b0a4559-21bc-4ebe-8abb-45f26c15a53b

Public Version Date

September 21, 2022

Public Version Number

1

DI Record Publish Date

September 13, 2022

Package DI Number

05060224336939

Quantity per Package

10

Contains DI Package

05060224332023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-