Catalog Number

-

Brand Name

NATURAL EXTENSIONS

Version/Model Number

3414-708

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)

-

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

89da51c8-cc08-4b8d-80d6-60013b480575

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

November 16, 2016

Package DI Number

10366975002034

Quantity per Package

50

Contains DI Package

00366975002037

Package Discontinue Date

-

Package Status

-

Package Type

CASE