Dr Scholls Freeze Away Dual Action 7ct Blue - Combination Cryogenic Wart Remover - SCHOLL'S WELLNESS COMPANY LLC

Duns Number:117174744

Device Description: Combination Cryogenic Wart Remover

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More Product Details

Catalog Number

-

Brand Name

Dr Scholls Freeze Away Dual Action 7ct Blue

Version/Model Number

90000120

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2023

Issuing Agency

In GS1

Product Characteristics

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

K031697,K031697

Product Code Details

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Device Record Status

Public Device Record Key

6e32ac16-1082-4a73-8310-9691fe3aceff

Public Version Date

January 14, 2021

Public Version Number

1

DI Record Publish Date

January 06, 2021

Additional Identifiers

Package DI Number

10888853000081

Quantity per Package

12

Contains DI Package

00888853000084

Package Discontinue Date

January 07, 2021

Package Status

Not in Commercial Distribution

Package Type

Case

"SCHOLL'S WELLNESS COMPANY LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5