Catalog Number

-

Brand Name

H-E-B

Version/Model Number

041220825240

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

5e1878b0-3cfa-4d4e-bea0-08340e499b3b

Public Version Date

August 04, 2020

Public Version Number

1

DI Record Publish Date

July 27, 2020

Package DI Number

20041220825244

Quantity per Package

36

Contains DI Package

00041220825240

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case