Catalog Number

5251-498

Brand Name

BENCO

Version/Model Number

5251-498

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"

Yes

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

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

5cd6be52-081b-4758-a8c3-2d84a7137ede

Public Version Date

March 08, 2021

Public Version Number

5

DI Record Publish Date

January 31, 2018

Package DI Number

10366975013030

Quantity per Package

10

Contains DI Package

00366975013033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE