Catalog Number

-

Brand Name

MAX-XF EXPANSION DENTAL FLOSS

Version/Model Number

6070541157

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

20fa5203-da28-4db0-8ccb-64d76623e110

Public Version Date

September 15, 2022

Public Version Number

1

DI Record Publish Date

September 07, 2022

Package DI Number

D89260705411572

Quantity per Package

1500

Contains DI Package

D89260705411571

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case