Catalog Number

-

Brand Name

DxTerity™ TRA

Version/Model Number

U6ULTRA35SH

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

2fba4218-7408-4464-bf1d-89bb52261cd7

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 11, 2018

Package DI Number

20763000016672

Quantity per Package

5

Contains DI Package

00763000016678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK