Catalog Number

SRD7040MB

Brand Name

SUPER TORQUE

Version/Model Number

SRD7040MB

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

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

K915836,K915836

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

00f6af7c-31cf-490e-b0a1-0760d9733e88

Public Version Date

September 14, 2022

Public Version Number

7

DI Record Publish Date

August 01, 2016

Package DI Number

20705032075203

Quantity per Package

5

Contains DI Package

10705032075206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX