Catalog Number

-

Brand Name

H-E-B

Version/Model Number

041220083251

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

667366a7-fdda-4a61-b169-e13d8107d91a

Public Version Date

August 04, 2020

Public Version Number

1

DI Record Publish Date

July 27, 2020

Package DI Number

20041220083255

Quantity per Package

48

Contains DI Package

00041220083251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case