pjur Light - Silicone-based Personal Lubricant - Pjur Group Luxembourg SA

Duns Number:400744553

Device Description: Silicone-based Personal Lubricant

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More Product Details

Catalog Number

-

Brand Name

pjur Light

Version/Model Number

pjur Light 30 ml - USA

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

Yes

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

K133336,K133336,K133336

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

c22e0c91-88d7-4fe6-b5ae-1e3f862527bf

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

May 01, 2017

Additional Identifiers

Package DI Number

40827160111982

Quantity per Package

28

Contains DI Package

10827160111981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"PJUR GROUP LUXEMBOURG SA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 58