Catalog Number

-

Brand Name

CVS Health

Version/Model Number

953438

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 13, 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"

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

80944d58-eda5-4ea2-8652-c4fe5ab4fa3f

Public Version Date

September 15, 2021

Public Version Number

2

DI Record Publish Date

September 30, 2019

Package DI Number

02005042829426

Quantity per Package

36

Contains DI Package

00050428294260

Package Discontinue Date

April 13, 2021

Package Status

Not in Commercial Distribution

Package Type

case