Catalog Number

-

Brand Name

Quality Choice

Version/Model Number

635515998551

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

5a0b2dde-e9c6-4498-a2b4-9f51e6cbf79f

Public Version Date

August 17, 2021

Public Version Number

1

DI Record Publish Date

August 09, 2021

Package DI Number

10635515998558

Quantity per Package

36

Contains DI Package

00635515998551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case