Catalog Number

-

Brand Name

GoodSense

Version/Model Number

846036004199

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

a257f91f-ff63-4cf8-ac1f-14d914770ef3

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 28, 2020

Package DI Number

10846036004196

Quantity per Package

36

Contains DI Package

00846036004199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case