Core Values

Basic Information

• Brand Name: Core Values
• Primary DI: 00017276232288
• Version / Model: 20464288
• Catalog Number: 20464288
• Company Name: HARMON STORES, INC.
• Labeler DUNS: 804085293
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-16
• Public Version: 4
• Public Version Date: 2021-08-17
• Public Version Status: Update
• Public Device Record Key: abade7d1-5f5c-40e8-9cf5-7727af176ff2
• Distribution End Date: 2018-10-08

Device Description

Advanced Wart Freezer One-Step Wart Remover

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	878.4350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42518	Wart-removal cryogenic kit	A collection of devices designed to apply cold from a liquid/gaseous refrigerant (cryogen) to a common or plantar (sole of foot) wart for its removal. The collection typically includes a pressurized cannister with a cryogenic mixture (e.g., liquid dimethyl ether and propane), disposable applicators, a reusable activator that releases the cryogen into the applicators, and cushions; it may also include a liquid wart remover (e.g., salicylic acid) for post-cryo treatment. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10017276232285	GS1	case	6	Not in Commercial Distribution	2018-10-08
Primary	00017276232288	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	155	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: between 20 and 25 Degree Celsius