Catalog Number

-

Brand Name

Tilcare Oral Dispenser with Cover

Version/Model Number

ORAL DISPENSER WITH COVER 10ML

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

KYX

Product Code Name

Dispenser, Liquid Medication

Public Device Record Key

581509bb-e822-49cb-a2be-9190fc9c2535

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2019

Package DI Number

25060665920159

Quantity per Package

600

Contains DI Package

05060665920155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-