Catalog Number

-

Brand Name

DxTerity™ TRA

Version/Model Number

U5ULTRA40SHA

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

K161287,K161287

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

0b5b27ff-e276-40d0-a4ff-b03a4f90d6ba

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 11, 2018

Package DI Number

20763000016788

Quantity per Package

5

Contains DI Package

00763000016784

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK