Catalog Number

18023

Brand Name

DLW,3LD, SNAP,36",NIHON KOHDEN

Version/Model Number

DLW-03AF-36AN-0000

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

-

Product Code

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Public Device Record Key

3e85de9c-2ea3-4e02-b25d-79cc8171b27c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

90840828100703

Quantity per Package

10

Contains DI Package

90840828100680

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-