Catalog Number

-

Brand Name

Equate

Version/Model Number

SRC

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

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

e82a8c86-a762-4393-bcb7-fb5f04a1eb45

Public Version Date

June 05, 2020

Public Version Number

1

DI Record Publish Date

May 28, 2020

Package DI Number

10681131346402

Quantity per Package

6

Contains DI Package

00681131346405

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner