Catalog Number

-

Brand Name

Members Mark

Version/Model Number

078742060583

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

4cf116dc-6766-4568-afbc-7c420cd8d4fb

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 27, 2020

Package DI Number

20078742094650

Quantity per Package

24

Contains DI Package

00078742060583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case