Catalog Number

651506000

Brand Name

Skater™ Introducer System

Version/Model Number

651506000

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

GCB

Product Code Name

Needle, Catheter

Public Device Record Key

b79bb844-eec3-41b8-99b8-2d40dac99880

Public Version Date

July 22, 2022

Public Version Number

1

DI Record Publish Date

July 14, 2022

Package DI Number

20886333004526

Quantity per Package

5

Contains DI Package

00886333004522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box