Catalog Number

755112035

Brand Name

SKATER™ Drainage Catheter

Version/Model Number

755112035E

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

8ff008e5-e5f6-487b-9807-bf138d8de1bb

Public Version Date

July 21, 2022

Public Version Number

1

DI Record Publish Date

July 13, 2022

Package DI Number

20886333000207

Quantity per Package

5

Contains DI Package

00886333000203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box