Catalog Number

12770-02

Brand Name

pjur analyse me! silicone

Version/Model Number

pjur analyse me! glide 250 ml - USA

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

K141913,K141913,K141913

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

19b4be45-426c-4c10-9201-c96556418353

Public Version Date

August 31, 2022

Public Version Number

3

DI Record Publish Date

December 04, 2018

Package DI Number

40827160112248

Quantity per Package

12

Contains DI Package

10827160112247

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case