Catalog Number

SRD5679

Brand Name

INFINITI

Version/Model Number

SRD5679

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

K960975,K960975

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

a08679cd-3157-4359-88dd-91ccc2ae7bb0

Public Version Date

September 14, 2022

Public Version Number

6

DI Record Publish Date

August 01, 2016

Package DI Number

20705032073889

Quantity per Package

5

Contains DI Package

10705032073882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX