Walgreens - 4oz (113g) Personal Lubricating Jelly - WALGREEN CO.

Duns Number:008965063

Device Description: 4oz (113g) Personal Lubricating Jelly

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More Product Details

Catalog Number

-

Brand Name

Walgreens

Version/Model Number

0F226

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 26, 2018

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

K012203,K012203

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

fc30428a-a9d7-4873-ab6c-0cf0e1f651e5

Public Version Date

January 30, 2020

Public Version Number

2

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

10311917205059

Quantity per Package

72

Contains DI Package

00311917205052

Package Discontinue Date

October 26, 2018

Package Status

Not in Commercial Distribution

Package Type

Shipper

"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