MASTISOL

Basic Information

• Brand Name: MASTISOL
• Primary DI: 00304960523488
• Version / Model: 1
• Catalog Number: 0523-48
• 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: c3f97791-d569-48a0-a400-e45a9824d7cd

Device Description

LIQUID ADHESIVE

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
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63509	Skin surface device adhesive, sterile	A sterile substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00304960523488	GS1

Customer Contacts

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