FDA UDI
In Commercial Distribution
🇺🇸 United States
Medical Precision Comfort Marker
DI: 08720165025039
·
Model: 2.0
·
Medical Precision B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medical Precision Comfort Marker
- Primary DI
- 08720165025039
- Version / Model
- 2.0
- Catalog Number
- 2012
- Company Name
- Medical Precision B.V.
- Labeler DUNS
- 491869820
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-12
- Public Version
- 1
- Public Version Date
- 2026-03-20
- Public Version Status
- New
- Public Device Record Key
- d87a1176-b30a-4428-8e3c-ddbcac006d02
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 | 08720165025039 | GS1 |
Customer Contacts
- Phone
- +310384657169
- [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.