Catalog Number

-

Brand Name

NA

Version/Model Number

DS-11-D

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

GXD

Product Code Name

GENERATOR, LESION, RADIOFREQUENCY

Public Device Record Key

2d16c0ba-8891-4235-bb72-e5bb8804a303

Public Version Date

October 08, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2017

Package DI Number

00813250014600

Quantity per Package

10

Contains DI Package

00813250014570

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-