Catalog Number

651006300

Brand Name

Skater™ Introducer Set

Version/Model Number

651006300

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

7ae6005f-9097-4dfe-b752-d3b2fe437ebc

Public Version Date

July 22, 2022

Public Version Number

1

DI Record Publish Date

July 14, 2022

Package DI Number

20886333223354

Quantity per Package

5

Contains DI Package

00886333223350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box