Hopkins Medical Products® - Procedure Mask PK50 - HOPKINS UNIFORM COMPANY

Duns Number:003080678

Device Description: Procedure Mask PK50

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More Product Details

Catalog Number

19696

Brand Name

Hopkins Medical Products®

Version/Model Number

19696

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FXX

Product Code Name

Mask, surgical

Device Record Status

Public Device Record Key

7cde9402-e05f-418e-b87f-a3039b3076a4

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

September 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOPKINS UNIFORM COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 96
2 A medical device with a moderate to high risk that requires special controls. 135