Catalog Number

-

Brand Name

Kroger

Version/Model Number

041260383816

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

LWF

Product Code Name

Dilator, Nasal

Public Device Record Key

18e59f87-a70c-4e40-81fe-28d9cd2a5d70

Public Version Date

June 30, 2020

Public Version Number

1

DI Record Publish Date

June 22, 2020

Package DI Number

10041260383813

Quantity per Package

36

Contains DI Package

00041260383816

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case