Catalog Number

-

Brand Name

STRING'EMS FLOSS THREADERS

Version/Model Number

6070541127

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

814be7c5-0c02-4137-85ec-6383e67c04a1

Public Version Date

September 27, 2022

Public Version Number

1

DI Record Publish Date

September 19, 2022

Package DI Number

D89760705411272

Quantity per Package

250

Contains DI Package

D89760705411271

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag