Catalog Number

DUG1SS/A

Brand Name

DugOut®

Version/Model Number

00884450027899

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Public Device Record Key

eb7ec4b5-6bce-4384-b56f-390ee846ec05

Public Version Date

April 23, 2018

Public Version Number

1

DI Record Publish Date

March 22, 2018

Package DI Number

10884450027896

Quantity per Package

6

Contains DI Package

00884450027899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-