Freeze Away 8ct

GUDID 10888853002962

Cryogenic Wart remover

SCHOLL'S WELLNESS COMPANY LLC

Wart-removal cryogenic kit
Primary Device ID10888853002962
NIH Device Record Key08da1bf6-d7ae-4cd9-b78e-7de6986a1ea6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeze Away 8ct
Version Model Number90000335
Company DUNS117174744
Company NameSCHOLL'S WELLNESS COMPANY LLC
Device Count8
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100888853002965 [Unit of Use]
GS110888853002962 [Primary]

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-19
Device Publish Date2022-07-11