Catalog Number

INT CSS

Brand Name

MEDRAD® Intego Sterile Disposables

Version/Model Number

INT CSS

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"

Yes

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

K080297,K080297,K080297

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

399b946d-4766-4152-af93-aef794d76c9f

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 05, 2018

Package DI Number

70616258020241

Quantity per Package

400

Contains DI Package

00616258020242

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-