Kroger - PTB POLARIS II SO - KROGER CO., THE

Duns Number:006999528

Device Description: PTB POLARIS II SO

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More Product Details

Catalog Number

-

Brand Name

Kroger

Version/Model Number

ULS

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JEQ

Product Code Name

Toothbrush, Powered

Device Record Status

Public Device Record Key

c77d6f97-6c02-4d13-9e3a-0324aa2045d9

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

May 15, 2020

Additional Identifiers

Package DI Number

20041260382707

Quantity per Package

6

Contains DI Package

00041260382703

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