Catalog Number

0406-630-125

Brand Name

NA

Version/Model Number

0406630125

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

1256be22-f64a-4dbe-8256-8c0759d42875

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

37613327118323

Quantity per Package

10

Contains DI Package

07613327118322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack