Catalog Number

MT-LA-04

Brand Name

Lead Adapter Cable

Version/Model Number

MT-LA-04-00823

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

-

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

K183123

Product Code

GZL

Product Code Name

ELECTRODE, DEPTH

Public Device Record Key

63fcd660-ba66-44c0-9e4e-367b0a46b8b5

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

February 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-