Catalog Number

-

Brand Name

Natural Extensions

Version/Model Number

3414-753

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)

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

50a2eed4-98b0-482c-ac7d-91d1c84d6be0

Public Version Date

May 06, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20366975000631

Quantity per Package

5

Contains DI Package

10366975000634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case