Catalog Number

-

Brand Name

PATTERSON

Version/Model Number

071133271

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K823078,K823078,K823078

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

ef821cc7-e42c-45da-991c-ab6ec606964d

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

D6620711332714

Quantity per Package

10

Contains DI Package

D6620711332712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE