Catalog Number

-

Brand Name

NA

Version/Model Number

PG-1018

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

a085af07-9a38-4d2c-a456-2432a6e0fa67

Public Version Date

January 17, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2018

Package DI Number

00813250017090

Quantity per Package

10

Contains DI Package

00813250017083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-