Q-Wire System
- Primary DI
- 04250195603036
- Brand
- Q-Wire System
- Company
- SOMATEX Medical Technologies GmbH
- Model
- 271464
- Published
- 2021-10-28
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| MIJ | Needle, Tumor Localization |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MIJ | Needle, Tumor Localization | General, Plastic Surgery | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04250195604606 | Package | GS1 | 10 | Not in Commercial Distribution |
| 04250195603036 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04250195604606 | 04250195604606 | 4250195604606 |
| 04250195603036 | 04250195603036 | 4250195603036 |
GMDN Terms#
| Term | Definition |
|---|---|
| Radiological image marker, implantable | A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. |
Regulatory Flags#
- DUNS number
- 341679629
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04250195600806 | TUMARK | 271550 | 271550 | 2015-10-27 |
| 04250195600813 | TUMARK Professional | 271560 | 271560 | 2015-10-30 |
| 04250195600820 | TUMARK Professional | 271565 | 271565 | 2015-10-30 |
| 04250195600837 | Tuloc | 271660 | 2021-10-28 | |
| 04250195600844 | Tuloc | 271661 | 2021-10-28 | |
| 04250195600851 | Tuloc | 271663 | 2021-10-28 | |
| 04250195600899 | Lung Marker System | 272012 | 2021-10-28 | |
| 04250195600905 | Lung Marker System | 272015 | 2021-10-28 | |
| 04250195601605 | MRI Tuloc | 601649 | 2021-10-28 | |
| 04250195601612 | MRI Tuloc | 601651 | 2021-10-28 | |
| 04250195601735 | MRI Biopsy Handy | 603110 | 2016-10-11 | |
| 04250195601858 | Biopsy Handy | 900120 | 2016-10-11 | |
| 04250195601865 | Biopsy Handy | 900122 | 2016-10-11 | |
| 04250195601872 | Biopsy Handy | 900126 | 2016-10-11 | |
| 04250195601889 | Biopsy Handy | 900128 | 2016-10-11 | |
| 04250195601896 | Biopsy Handy | 900130 | 2016-10-11 | |
| 04250195601902 | Biopsy Handy | 900134 | 2016-10-11 | |
| 04250195601926 | Biopsy Handy | 900138 | 2016-10-11 | |
| 04250195601933 | Biopsy Handy | 900142 | 2016-10-11 | |
| 04250195601940 | Biopsy Handy | 900144 | 2016-10-11 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00860009883703 | Mammo-Flex Quad-Flex Localization System | Dfc Medical LLC | MIJ | 2023-10-17 |
| 08033003340349 | ALM SET | H.S. HOSPITAL SERVICE SPA | MIJ | 2023-04-19 |
| 48033003340347 | ALM SET | H.S. HOSPITAL SERVICE SPA | MIJ | 2023-04-19 |
| 08059174746964 | MEDWIRE | MEDAX SRL UNIPERSONALE | MIJ | 2023-01-03 |
| 08059174747084 | MEDWIRE | MEDAX SRL UNIPERSONALE | MIJ | 2023-01-03 |
| 08059174746971 | MEDWIRE | MEDAX SRL UNIPERSONALE | MIJ | 2022-12-20 |
| 08059174747008 | MEDWIRE | MEDAX SRL UNIPERSONALE | MIJ | 2022-12-20 |
| 08059174747091 | MEDWIRE | MEDAX SRL UNIPERSONALE | MIJ | 2022-12-20 |
| 08059174747107 | MEDWIRE | MEDAX SRL UNIPERSONALE | MIJ | 2022-12-20 |
| 08059174747121 | MEDWIRE | MEDAX SRL UNIPERSONALE | MIJ | 2022-12-20 |
| 08059174746988 | MEDWIRE | MEDAX SRL UNIPERSONALE | MIJ | 2022-07-15 |
| 18059174746985 | MEDWIRE | MEDAX SRL UNIPERSONALE | MIJ | 2022-07-15 |
| 04250195600837 | Tuloc | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195600844 | Tuloc | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195600851 | Tuloc | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195600899 | Lung Marker System | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195600905 | Lung Marker System | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195601605 | MRI Tuloc | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195601612 | MRI Tuloc | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195602046 | Tuloc Premium | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195602053 | Tuloc Premium | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195602060 | Tuloc Premium | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195603005 | Q-Wire System | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195603029 | Q-Wire System | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195604705 | Tuloc | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195604712 | Tuloc | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195604729 | Tuloc | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195604798 | Lung Marker System | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195604804 | Lung Marker System | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |
| 04250195605825 | MRI Tuloc | SOMATEX Medical Technologies GmbH | MIJ | 2021-10-28 |