Catalog Number

-

Brand Name

NA

Version/Model Number

1035DW

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

P020045

Product Code

LPB

Product Code Name

Cardiac ablation percutaneous catheter

Public Device Record Key

efdc243e-14eb-481f-8482-3853ecd5d0aa

Public Version Date

July 04, 2022

Public Version Number

4

DI Record Publish Date

May 19, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-