Catalog Number

8901

Brand Name

LW TWINPIN,5PKG,SLW,SNAP,51",(BL)

Version/Model Number

LDW-05AB-51A2-0000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 14, 2020

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

-

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

K081762

Product Code

DSA

Product Code Name

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

Public Device Record Key

87a65ebd-5555-4ee5-80b6-850ed3b2dc43

Public Version Date

February 14, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-