IsoMark™

Basic Information

• Brand Name: IsoMark™
• Primary DI: 00714646000910
• Version / Model: UTRT-3101
• Catalog Number: 3101
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-10-27
• Public Version: 3
• Public Version Date: 2023-07-17
• Public Version Status: Update
• Public Device Record Key: 5d5fbbe6-8143-466a-8bbd-1db271e48158

Device Description

IsoMark™ Black Ink

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZZ	MARKER, SKIN	General, Plastic Surgery	878.4660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61783	Tattoo ink, dermal	A sterile, synthetic, implantable dye solution intended to be injected between the layers of the skin, using a tattoo needle and hand-held ink injector, for aesthetic pigmentation of the skin and visible mucous membranes. It is typically pH balanced for dermal applications and does not contain animal-derived materials. It may be implanted for a variety of reasons (e.g., for cosmetic decoration, to replace colour in the skin for patients affected by pigment deficiencies, for radiotherapy marking).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00714646000934	GS1
Primary	00714646000910	GS1

Customer Contacts

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