Catalog Number

-

Brand Name

Dr Scholls Freeze Away Max Wart Remover

Version/Model Number

90000067

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 04, 2023

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

K201366,K201366

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

0836f1ba-39f4-4e58-970b-7dfdcd92e1e8

Public Version Date

February 11, 2021

Public Version Number

1

DI Record Publish Date

February 03, 2021

Package DI Number

10888853000616

Quantity per Package

12

Contains DI Package

00888853000619

Package Discontinue Date

March 03, 2023

Package Status

In Commercial Distribution

Package Type

Case