SportLube - WESTRIDGE LABORATORIES INCORPORATED

Duns Number:879057065

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More Product Details

Catalog Number

-

Brand Name

SportLube

Version/Model Number

SportLube 3.4 fl oz Silicone Based

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

084a392f-5e3c-4877-a10a-d01535180037

Public Version Date

August 07, 2020

Public Version Number

3

DI Record Publish Date

March 06, 2018

Additional Identifiers

Package DI Number

40865542000349

Quantity per Package

24

Contains DI Package

00865542000341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"WESTRIDGE LABORATORIES INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 56