Medical Precision Comfort Marker
- Primary DI
- 78720165025007
- 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
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| QRN | Radiation Therapy Marking Device |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QRN | Radiation Therapy Marking Device | Radiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08720165025008 | Primary | GS1 | 0 | |
| 78720165025007 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08720165025008 | 08720165025008 | 8720165025008 |
| 78720165025007 | 78720165025007 | |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | 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. |
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 85 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 32 Degrees Fahrenheit | 104 Degrees Fahrenheit | |
Contacts
| Phone | Email |
|---|
| +310384657169 | info@medicalprecision.nl |
Regulatory Flags
- DUNS number
- 491869820
- Device count
- 25
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 08720165025022 | Medical Precision Comfort Marker | 2.0 | 2011 | 2026-03-12 |
| 08720165025039 | Medical Precision Comfort Marker | 2.0 | 2012 | 2026-03-12 |
| 78720165025014 | Medical Precision Comfort Marker | 2.0 | 2022 | 2026-03-11 |
| 08720165025046 | Medical Precision Comfort Marker | 2.0 | 2010 | 2026-03-11 |
| 08720165025053 | Medical Precision Comfort Marker | 2.0 | 2010-T1 | 2026-03-11 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 08720165025022 | Medical Precision Comfort Marker | Medical Precision B.V. | QRN | 2026-03-12 |
| 08720165025039 | Medical Precision Comfort Marker | Medical Precision B.V. | QRN | 2026-03-12 |
| 78720165025014 | Medical Precision Comfort Marker | Medical Precision B.V. | QRN | 2026-03-11 |
| 08720165025046 | Medical Precision Comfort Marker | Medical Precision B.V. | QRN | 2026-03-11 |
| 08720165025053 | Medical Precision Comfort Marker | Medical Precision B.V. | QRN | 2026-03-11 |
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