Catalog Number

STR-S00766-00

Brand Name

LeadConfirm

Version/Model Number

Sterile NeuroSmart/NeuroNav MER LeadConfirm M_S Cable

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K191739,K191739

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

6698d5e9-a251-4eb9-a2ff-12ec650622d5

Public Version Date

May 14, 2021

Public Version Number

2

DI Record Publish Date

February 17, 2021

Package DI Number

17290114061084

Quantity per Package

10

Contains DI Package

07290114061087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton