Catalog Number

13968-02

Brand Name

pjur INFINITY water-based

Version/Model Number

pjur INFINITY water-based, 50ml

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

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

K200730,K200730,K200730

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

672a2b4d-fe5f-4e3d-aacf-fe8767bd7f7a

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Package DI Number

10827160115170

Quantity per Package

6

Contains DI Package

00827160115173

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack