Catalog Number

CAR-1615S

Brand Name

Surge Cardiovascular

Version/Model Number

CAR-1615S

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

6c9a223d-43fc-4674-861b-3e6286aba87e

Public Version Date

September 21, 2022

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

10817278010276

Quantity per Package

10

Contains DI Package

00817278010279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case