Catalog Number

ADV2316

Brand Name

Advance Plus™ Earloop Procedure Masks

Version/Model Number

ADV2316

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

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

5734bb4f-ee44-42bd-af50-6ce53ba0123a

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

March 10, 2020

Package DI Number

20810012650032

Quantity per Package

10

Contains DI Package

10810012650035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case