Catalog Number

5756NS

Brand Name

Surge Cardiovascular

Version/Model Number

5756NS

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

-

Product Code

GFA

Product Code Name

Blade, Saw, General & Plastic Surgery, Surgical

Public Device Record Key

f984fbed-82be-4da7-b144-cf6fe89fbeee

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

March 27, 2018

Package DI Number

30817278011697

Quantity per Package

30

Contains DI Package

00817278011696

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case