Catalog Number

9009-993

Brand Name

SCANLAN® Suction System Devices

Version/Model Number

9009-993

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

-

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

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

533aeb2e-a80c-4ad1-b7fe-2c66545cd8a8

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

July 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-