Catalog Number

SHI SM 2005X

Brand Name

SHIELDMATE

Version/Model Number

SHI SM 2005X

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

K882028,K882028,K882028

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

cfd2af72-45af-48ad-91c8-eaeb404c7a3c

Public Version Date

July 07, 2020

Public Version Number

5

DI Record Publish Date

November 03, 2016

Package DI Number

20817583020554

Quantity per Package

4

Contains DI Package

10817583020557

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE