Catalog Number

-

Brand Name

Grafco

Version/Model Number

3813B

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

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

b8300ec4-67f5-4f59-ab37-ea4730eff6d3

Public Version Date

August 31, 2020

Public Version Number

6

DI Record Publish Date

August 31, 2016

Package DI Number

M3683813B2

Quantity per Package

10

Contains DI Package

M3683813B1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-