Catalog Number

-

Brand Name

Patterson

Version/Model Number

85894

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

K133070,K133070,K133070

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

e4018404-eb67-43ef-afb1-36a91d033d5b

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 15, 2017

Package DI Number

20889215858941

Quantity per Package

12

Contains DI Package

10889215858944

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case