Catalog Number

973212

Brand Name

Well at Walgreens

Version/Model Number

189604

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 21, 2016

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

K060145,K060145,K060145

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

900f3fa7-b9b9-4742-87ac-2d11caa2727f

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

November 16, 2016

Package DI Number

1031191718961

Quantity per Package

24

Contains DI Package

00311917189604

Package Discontinue Date

November 21, 2016

Package Status

Not in Commercial Distribution

Package Type

Case