Catalog Number

PFL008-1

Brand Name

Shield

Version/Model Number

PFL008

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"

Yes

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

K890128,K890128,K890128

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

e069ecc6-a213-4520-a1d9-b42b50fef61b

Public Version Date

November 01, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

H816PFL0082

Quantity per Package

6

Contains DI Package

H816PFL0081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Box