Well at Walgreens - This device is a personal lubricant, for penile - WALGREEN CO.

Duns Number:008965063

Device Description: This device is a personal lubricant, for penile and/or vaginal application, intended to mo This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.

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More Product Details

Catalog Number

80029

Brand Name

Well at Walgreens

Version/Model Number

80029

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

-

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

K062682,K062682

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

1df392dd-91e6-48b1-834a-d704656085c4

Public Version Date

August 07, 2020

Public Version Number

6

DI Record Publish Date

November 16, 2016

Additional Identifiers

Package DI Number

10311917186273

Quantity per Package

24

Contains DI Package

00311917186276

Package Discontinue Date

November 21, 2016

Package Status

Not in Commercial Distribution

Package Type

Case

"WALGREEN CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 75
2 A medical device with a moderate to high risk that requires special controls. 74
U Unclassified 2