Surge Cardiovascular - Retrograde Cardioplegia Cannula, Self Inflating - Med Michigan Holdings, LLC

Duns Number:097462979

Device Description: Retrograde Cardioplegia Cannula, Self Inflating Textured Balloon (18mm) & Guidewire Stylet Retrograde Cardioplegia Cannula, Self Inflating Textured Balloon (18mm) & Guidewire Stylet 15Fr

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More Product Details

Catalog Number

RSG-T014S

Brand Name

Surge Cardiovascular

Version/Model Number

RSG-T014S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

54cac994-a68e-4fe1-896e-e97e4c62c580

Public Version Date

September 21, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10817278011907

Quantity per Package

5

Contains DI Package

00817278011900

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MED MICHIGAN HOLDINGS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 91