Catalog Number

CAR-1613

Brand Name

Surge Cardiovascular

Version/Model Number

CAR-1613

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

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Public Device Record Key

c73f4c7b-d3a8-4c13-b94f-b4d6137a6b33

Public Version Date

September 21, 2022

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

20817278011355

Quantity per Package

4

Contains DI Package

10817278011358

Package Discontinue Date

March 26, 2018

Package Status

Not in Commercial Distribution

Package Type

Case