Catalog Number

STR-000055-00

Brand Name

LeadConfirm

Version/Model Number

Sterile Neuro Omega LeadConfirm B 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)

-

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

1cec0107-c43a-437c-a766-121ddf1ca0a3

Public Version Date

May 14, 2021

Public Version Number

2

DI Record Publish Date

March 04, 2021

Package DI Number

17290114060421

Quantity per Package

10

Contains DI Package

07290114060424

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton