Catalog Number

700-083

Brand Name

Self Oral Care Kit

Version/Model Number

700-083

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2019

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

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

d869a7be-d599-4c47-a970-d6ab3d3043c4

Public Version Date

July 26, 2022

Public Version Number

3

DI Record Publish Date

December 10, 2018

Package DI Number

50618029980026

Quantity per Package

24

Contains DI Package

00618029980021

Package Discontinue Date

April 30, 2019

Package Status

Not in Commercial Distribution

Package Type

case