Catalog Number

-

Brand Name

Ezy Dose

Version/Model Number

400491/400491A

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"

-

For Single-Use

-

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

LJL

Product Code Name

Detectors And Removers, Lice, (Including Combs)

Public Device Record Key

30574dae-9411-4405-8baf-2e2211d82aff

Public Version Date

October 26, 2020

Public Version Number

1

DI Record Publish Date

October 16, 2020

Package DI Number

10079573104917

Quantity per Package

6

Contains DI Package

00079573104910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner