Catalog Number

-

Brand Name

Equate

Version/Model Number

UQW

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

973e9559-c3a4-48aa-907e-a01961d331fd

Public Version Date

July 01, 2020

Public Version Number

1

DI Record Publish Date

June 23, 2020

Package DI Number

20681131071080

Quantity per Package

72

Contains DI Package

00681131071086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case