Catalog Number

RLV AK05

Brand Name

Intracept

Version/Model Number

FG 0060

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

0199a7f1-b648-4a2b-8054-0a4b7c24108f

Public Version Date

February 15, 2019

Public Version Number

1

DI Record Publish Date

January 15, 2019

Package DI Number

10852454006186

Quantity per Package

5

Contains DI Package

00852454006189

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-