Catalog Number

-

Brand Name

Johnson & Johnson Reach

Version/Model Number

00381370092179

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 02, 2022

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JES

Product Code Name

FLOSS, DENTAL

Public Device Record Key

c5945ded-6b0f-4b7e-b68a-f01913632bcf

Public Version Date

May 02, 2022

Public Version Number

3

DI Record Publish Date

September 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-