Catalog Number

LW-309DS50/5AT

Brand Name

N/A

Version/Model Number

LW-309DS50/5AT

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"

Yes

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

IKD

Product Code Name

CABLE, ELECTRODE

Public Device Record Key

7efec4e5-e1c8-4f0b-b6f5-f4c433a45563

Public Version Date

April 28, 2022

Public Version Number

2

DI Record Publish Date

May 10, 2019

Package DI Number

57613327481995

Quantity per Package

25

Contains DI Package

07613327481990

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case