Catalog Number

336146

Brand Name

Well at Walgreens

Version/Model Number

336146

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 26, 2018

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

-

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

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

8facc951-96d9-472a-80e2-73ccf48bfad9

Public Version Date

August 14, 2019

Public Version Number

4

DI Record Publish Date

August 15, 2016

Package DI Number

10311917164295

Quantity per Package

6

Contains DI Package

00311917164298

Package Discontinue Date

March 13, 2018

Package Status

Not in Commercial Distribution

Package Type

Case