Catalog Number

-

Brand Name

SportLube

Version/Model Number

Sportlube 8.1 fl oz Water Based

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051295,K051295

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

6fe37a2d-6121-401c-acba-452ae8aa84d2

Public Version Date

August 07, 2020

Public Version Number

4

DI Record Publish Date

March 06, 2018

Package DI Number

30865542000328

Quantity per Package

12

Contains DI Package

00865542000327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case