Catalog Number

SHI BL 8101 S

Brand Name

SHIELDMATE

Version/Model Number

SHI BL 8101 S

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

K882027,K882027,K882027

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

11adb74a-6f68-4147-8b3d-ac41f6deb26f

Public Version Date

July 07, 2020

Public Version Number

5

DI Record Publish Date

November 03, 2016

Package DI Number

20817583020530

Quantity per Package

4

Contains DI Package

10817583020533

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE