Catalog Number

-

Brand Name

Well at Walgreens

Version/Model Number

129810

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

37384dff-ff4a-44d6-af24-d2a46487d0c8

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

10311917221196

Quantity per Package

40

Contains DI Package

00311917221199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case