Catalog Number

-

Brand Name

Signature Care

Version/Model Number

321130778691

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

0f37ed17-578f-4a86-a30b-d1da5933d41c

Public Version Date

September 27, 2021

Public Version Number

2

DI Record Publish Date

August 10, 2020

Package DI Number

10321130778698

Quantity per Package

36

Contains DI Package

00321130778691

Package Discontinue Date

August 04, 2020

Package Status

Not in Commercial Distribution

Package Type

case