Arcwave by pjur - Water-based Personal Lubricant - Pjur Group Luxembourg SA

Duns Number:400744553

Device Description: Water-based Personal Lubricant

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More Product Details

Catalog Number

-

Brand Name

Arcwave by pjur

Version/Model Number

Arcwave by pjur - 100ml - 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

K010199,K010199,K010199

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

352ad446-7591-43c6-8eb8-03ea3c8cba91

Public Version Date

November 10, 2020

Public Version Number

1

DI Record Publish Date

November 02, 2020

Additional Identifiers

Package DI Number

10827160114739

Quantity per Package

6

Contains DI Package

00827160114732

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack

"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