Catalog Number

-

Brand Name

OROCARE ASPIRE SUCTION TOOTHBRUSH

Version/Model Number

3016000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

4a1c09b1-e6f8-4f50-b7b7-554aab26b855

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 15, 2021

Package DI Number

05030267126224

Quantity per Package

100

Contains DI Package

05030267120581

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-