Catalog Number

695197

Brand Name

Hopkins Medical Products®

Version/Model Number

695197

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K940720

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

c7c500d6-1f7b-4ac4-9759-bef60ea1c5d3

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

October 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-