Catalog Number

384673

Brand Name

Well at Walgreens

Version/Model Number

384673

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2020

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063043,K063043,K063043

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

feac7e48-7261-433c-8b11-9a94177ff86d

Public Version Date

August 16, 2021

Public Version Number

6

DI Record Publish Date

February 24, 2017

Package DI Number

10311917174195

Quantity per Package

24

Contains DI Package

00311917174198

Package Discontinue Date

August 31, 2020

Package Status

Not in Commercial Distribution

Package Type

Case