FDA.reportPublic FDA data

Medical Precision Comfort Marker

Primary DI
08720165025015
Brand
Medical Precision Comfort Marker
Company
Medical Precision B.V.
Model
2.0
Catalog number
2022
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.
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRNRadiation Therapy Marking Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRNRadiation Therapy Marking DeviceRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720165025015PrimaryGS10
78720165025014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720165025015087201650250158720165025015
7872016502501478720165025014

GMDN Terms#

Term, Definition table
TermDefinition
Tattoo needleA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do 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.
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+310384657169info@medicalprecision.nl

Regulatory Flags#

DUNS number
491869820
Device count
500
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720165025022Medical Precision Comfort Marker2.020112026-03-12
08720165025039Medical Precision Comfort Marker2.020122026-03-12
08720165025008Medical Precision Comfort Marker2.020222026-03-11
78720165025007Medical Precision Comfort Marker2.020222026-03-11
78720165025014Medical Precision Comfort Marker2.020222026-03-11
08720165025046Medical Precision Comfort Marker2.020102026-03-11
08720165025053Medical Precision Comfort Marker2.02010-T12026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720165025022Medical Precision Comfort MarkerMedical Precision B.V.QRN2026-03-12
08720165025039Medical Precision Comfort MarkerMedical Precision B.V.QRN2026-03-12
08720165025008Medical Precision Comfort MarkerMedical Precision B.V.QRN2026-03-11
78720165025007Medical Precision Comfort MarkerMedical Precision B.V.QRN2026-03-11
78720165025014Medical Precision Comfort MarkerMedical Precision B.V.QRN2026-03-11
08720165025046Medical Precision Comfort MarkerMedical Precision B.V.QRN2026-03-11
08720165025053Medical Precision Comfort MarkerMedical Precision B.V.QRN2026-03-11