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

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

209bf295-403f-43f0-ac8b-b528284bccc4

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Package DI Number

40616258021476

Quantity per Package

20

Contains DI Package

00616258021478

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-