Catalog Number

700305010

Brand Name

Skater™ Centesis Catheter

Version/Model Number

700305010

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

GBQ

Product Code Name

Catheter, Continuous Irrigation

Public Device Record Key

3c1852c1-b517-4cdf-a4f1-5b17e91c4137

Public Version Date

July 20, 2022

Public Version Number

1

DI Record Publish Date

July 12, 2022

Package DI Number

20886333005806

Quantity per Package

5

Contains DI Package

00886333005802

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box