Catalog Number

-

Brand Name

Dr Scholls Freeze Away 7ct Yellow

Version/Model Number

90000090

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 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

K052259,K052259

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

b299d0af-3557-44c3-a64b-6c2865f7c70d

Public Version Date

January 14, 2021

Public Version Number

1

DI Record Publish Date

January 06, 2021

Package DI Number

10888853000050

Quantity per Package

12

Contains DI Package

00888853000053

Package Discontinue Date

January 06, 2021

Package Status

Not in Commercial Distribution

Package Type

Case