Catalog Number

5568

Brand Name

TRAPLINER

Version/Model Number

IPN914359

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

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

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

bc0dbb8e-8e5f-4cb9-8cb5-1e326f3e2a4c

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

October 01, 2018

Package DI Number

20841156102149

Quantity per Package

1

Contains DI Package

10841156102142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box