Catalog Number

-

Brand Name

Assured

Version/Model Number

218039

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2021

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"

-

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

LWF

Product Code Name

Dilator, Nasal

Public Device Record Key

4817f7c0-b234-4965-913f-04f4b3399b76

Public Version Date

August 20, 2021

Public Version Number

2

DI Record Publish Date

May 29, 2020

Package DI Number

20639277082279

Quantity per Package

24

Contains DI Package

00639277082275

Package Discontinue Date

March 09, 2021

Package Status

Not in Commercial Distribution

Package Type

case