MedSource Face Shield - Face Shield - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: Face Shield

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

Not Applicable

Brand Name

MedSource Face Shield

Version/Model Number

MS-12101

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KGB

Product Code Name

Mask, Oxygen, Non-Rebreathing

Device Record Status

Public Device Record Key

1f2f952d-c919-4fb8-900f-8dd75b4bf523

Public Version Date

May 07, 2021

Public Version Number

1

DI Record Publish Date

April 29, 2021

Additional Identifiers

Package DI Number

00840155400689

Quantity per Package

120

Contains DI Package

00840155400672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90