Catalog Number

Q48035

Brand Name

QUALA

Version/Model Number

Q48035

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

-

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

2bee477a-317c-41b4-bb59-2a277383e642

Public Version Date

October 24, 2018

Public Version Number

1

DI Record Publish Date

September 23, 2018

Package DI Number

D023Q480353

Quantity per Package

72

Contains DI Package

D023Q480351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-