ClearPoint
- Primary DI
- 08503590070375
- Brand
- ClearPoint
- Company
- CLEARPOINT NEURO, INC.
- Model
- NGS-BM-05
- Catalog number
- NGS-BM-05
- Device description
- ClearPoint MRI Fiducial Markers
- Published
- 2016-08-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri | Neurology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08503590070375 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08503590070375 | 08503590070375 | 8503590070375 |
GMDN Terms
| Term | Definition |
|---|
| Electromagnetic device tracking system fiducial marker | A non-sterile device intended to be used with an electromagnetic device tracking system to provide a physician with an external fixed reference point on the patient's body for the electromagnetic (EM) tracking of instruments inside the patient using pre-acquired images [e.g., computed tomography (CT) or magnetic resonance imaging (MRI)], or real-time image data and to join the imported CT and MRI images with real-time ultrasound (US). It typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an EM sensor for active registration. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 40 Degrees Fahrenheit | 90 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 959181160
- Device count
- 1
- 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
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00850376007758 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2022-01-31 |
| 00850376007598 | SmartFrame Array | CLEARPOINT NEURO, INC. | ORR | 2021-07-14 |
| 00850376007604 | Array | CLEARPOINT NEURO, INC. | ORR | 2021-07-14 |
| 00850376007628 | Array | CLEARPOINT NEURO, INC. | ORR | 2021-07-14 |
| 00850376007635 | Array | CLEARPOINT NEURO, INC. | ORR | 2021-07-14 |
| 00850359007744 | ClearPoint Array | CLEARPOINT NEURO, INC. | ORR | 2021-04-07 |
| 00850359007911 | ClearPoint Array Workstation | CLEARPOINT NEURO, INC. | ORR | 2021-04-07 |
| 00850359007959 | SmartTip | CLEARPOINT NEURO, INC. | ORR | 2021-04-07 |
| 00850359007072 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007089 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007096 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007102 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007119 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007126 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007133 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007140 | SmartGrid | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007157 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007164 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007171 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007188 | ClearPoint | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007195 | ClearPoint | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007201 | ClearPoint | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007218 | ClearPoint | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007225 | ClearPoint | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007232 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007249 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007256 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007263 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007270 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
| 00850359007287 | SmartFrame | CLEARPOINT NEURO, INC. | ORR | 2021-01-22 |
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