Kroger - FLOSS EXTRA COMFORT MINT - KROGER CO., THE

Duns Number:006999528

Device Description: FLOSS EXTRA COMFORT MINT

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More Product Details

Catalog Number

-

Brand Name

Kroger

Version/Model Number

UQW

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JES

Product Code Name

Floss, Dental

Device Record Status

Public Device Record Key

db6a7240-0963-4e05-84d8-64f29f4c7af6

Public Version Date

May 25, 2020

Public Version Number

1

DI Record Publish Date

May 15, 2020

Additional Identifiers

Package DI Number

10041260376839

Quantity per Package

72

Contains DI Package

00041260376832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"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