Kroger - Lubricating Jelly4oz (113g) - KROGER CO., THE

Duns Number:006999528

Device Description: Lubricating Jelly4oz (113g)

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More Product Details

Catalog Number

-

Brand Name

Kroger

Version/Model Number

7W92645C2

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

K012203,K012203,K012203

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

abb9f37f-6110-4c09-bc5c-0454ce9ae256

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Additional Identifiers

Package DI Number

20041260332252

Quantity per Package

6

Contains DI Package

00011110384492

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner

"KROGER CO., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 15