Medical Precision Comfort Marker

Basic Information

• Brand Name: Medical Precision Comfort Marker
• Primary DI: 08720165025046
• Version / Model: 2.0
• Catalog Number: 2010
• Company Name: Medical Precision B.V.
• Labeler DUNS: 491869820
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-11
• Public Version: 1
• Public Version Date: 2026-03-19
• Public Version Status: New
• Public Device Record Key: ca4d503c-2bd0-4867-9e54-3d57d46bb633

Device Description

Comfort Marker 2.0 is an application system for placing reference marks on patients eligible for Radiotherapy treatments. The Comfort Marker 2.0 allows the user to place accurate tattoo markers (reference points) on patients enabling radio therapy. The device consists of a Control and Pen module which drives a Safety Needle. Different depth settings can be chosen to accommodate for different skin types. When the tattoo marking has been placed the Control Unit can be stored and charged in the Docking station.

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
QRN	Radiation Therapy Marking Device	Radiology	892.5785	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17660	Tattoo ink injector	A hand-held mains electricity (AC-powered) device intended to accept a tattoo needle to percutaneously inject tattoo ink between the layers of the skin. It is intended to be used to tattoo the body with cosmetic decorations and adornments to replace colour in the skin, typically for patients affected by pigment deficiencies (e.g., to cover scars and burns, provide artificial eyebrows, give natural appearance to the nipples after breast reconstructive surgery, or to enhance eyes and lips). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720165025046	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 113 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: User is advised to consult the Instruction for Use.