Kroger - Antibacterial Gauze Pads, all one size, 2 IN x 2 - KROGER CO., THE

Duns Number:006999528

Device Description: Antibacterial Gauze Pads, all one size, 2 IN x 2 IN, 2 pads per wrapper. Contains: Polyhex Antibacterial Gauze Pads, all one size, 2 IN x 2 IN, 2 pads per wrapper. Contains: Polyhexamethylene Biguadine (PHMB) 0.2%

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More Product Details

Catalog Number

-

Brand Name

Kroger

Version/Model Number

041260377518

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"

Yes

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

-

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

28602b8d-57d9-4db2-a3b1-ea83042a8152

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

October 30, 2019

Additional Identifiers

Package DI Number

10041260377515

Quantity per Package

72

Contains DI Package

00041260377518

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