DxTerity™ TRA - CATH U5TRACTSHA DXT 5F 5PK 110CM TRACT - MEDTRONIC, INC.

Duns Number:006261481

Device Description: CATH U5TRACTSHA DXT 5F 5PK 110CM TRACT

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More Product Details

Catalog Number

-

Brand Name

DxTerity™ TRA

Version/Model Number

U5TRACTSHA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Record Status

Public Device Record Key

7ed1373e-c6ab-4a1a-a806-6adcf01078cb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 16, 2017

Additional Identifiers

Package DI Number

20643169739134

Quantity per Package

5

Contains DI Package

00643169739130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK

"MEDTRONIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 20495
3 A medical device with high risk that requires premarket approval 3601