Catalog Number

RLV AKA05

Brand Name

Intracept

Version/Model Number

FG 0046

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

4397de01-0451-42dc-9a98-5872c623920c

Public Version Date

May 02, 2018

Public Version Number

1

DI Record Publish Date

April 01, 2018

Package DI Number

10852454006032

Quantity per Package

5

Contains DI Package

00852454006035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-