DETACHOL

Basic Information

• Brand Name: DETACHOL
• Primary DI: 00304960513045
• Version / Model: 1
• Catalog Number: 0513-04
• Company Name: FERNDALE LABORATORIES, INC.
• Labeler DUNS: 005320536
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-19
• Public Version: 1
• Public Version Date: 2022-09-27
• Public Version Status: New
• Public Device Record Key: 835c9808-7f67-4a66-b605-2959f0a10d0c

Device Description

ADHESIVE REMOVER

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	878.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60494	Patient medical adhesive remover	A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00304960513045	GS1

Customer Contacts

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