Catalog Number

D7T20282CT

Brand Name

Biosense Webster

Version/Model Number

D7T20282CT

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

NLH

Product Code Name

CATHETER, RECORDING, ELECTRODE, REPROCESSED

Public Device Record Key

6ad0e095-9ad2-48da-b4c3-e1741e06f6f1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-