Catalog Number

-

Brand Name

EZY DOSE KIDS

Version/Model Number

69755

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

FXF

Product Code Name

Speculum, Illuminated

Public Device Record Key

69d97442-6192-4621-99ad-2d4c419e469b

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

September 09, 2020

Package DI Number

20025715697554

Quantity per Package

2

Contains DI Package

00025715697550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG