Catalog Number

3303

Brand Name

PremierPro

Version/Model Number

3303

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"

Yes

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

KMJ

Product Code Name

Lubricant, Patient

Public Device Record Key

8bcaac0c-944f-4f19-b22f-35b464d75f1b

Public Version Date

August 12, 2020

Public Version Number

1

DI Record Publish Date

August 04, 2020

Package DI Number

10818566013535

Quantity per Package

144

Contains DI Package

00818566013538

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box