Medical Precision Comfort Marker

Basic Information

• Brand Name: Medical Precision Comfort Marker
• Primary DI: 08720165025015
• Version / Model: 2.0
• Catalog Number: 2022
• Company Name: Medical Precision B.V.
• Labeler DUNS: 491869820
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• 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: e414cd31-5a5f-45ce-b032-33148b199086

Device Description

The Safety Needle is a sterile, single use device, always to be used in combination with the Control unit and Pen of the Comfort Marker 2.0 for applying ink to the skin with a controlled depth on human skin to identify the margins for radiation therapy.

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: MR Unsafe
• 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: Yes
• 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
47583	Tattoo needle	A sterile, sharp bevel-edged, hollow tubular metal instrument with a fixation anchor (e.g., an eyehole loop) at the proximal end that is inserted into a tattooing handpiece and is used to puncture and insert ink between the layers of the skin to create a tattoo. Tattoos are applied to the body as cosmetic decorations and adornments and to replace colour in the skin for patients suffering cosmetic 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	78720165025014	GS1
Primary	08720165025015	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged, Keep away from sunlight, Fragile handle with care, Keep dry, User is advised to consult the Instruction for Use.