Catalog Number

700508012

Brand Name

Skater™ Safety Centesis Catheter

Version/Model Number

700508012

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

OJT

Product Code Name

Aspiration Tray

Public Device Record Key

8cadecd2-81c6-4b54-bd3e-6f4ba8ff01ad

Public Version Date

July 28, 2022

Public Version Number

1

DI Record Publish Date

July 20, 2022

Package DI Number

20886333225044

Quantity per Package

10

Contains DI Package

00886333225040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box