Catalog Number

-

Brand Name

FLENTS

Version/Model Number

65400

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2017

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

3ea65d51-ab80-4b4a-9a8a-e6d003eebaec

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 06, 2016

Package DI Number

10025715041244

Quantity per Package

6

Contains DI Package

20023185003448

Package Discontinue Date

September 28, 2017

Package Status

Not in Commercial Distribution

Package Type

BOX