SmartTwist NGS-HD-01
GUDID 00850359007034
SmartTwist MRII Hand Drill
MRI INTERVENTIONS, INC.
Manual cranial rotary handpiece, single-use Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system| Primary Device ID | 00850359007034 |
| NIH Device Record Key | e2fbbfe7-95a0-4cc3-a003-5fdb5f910534 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartTwist |
| Version Model Number | NGS-HD-01 |
| Catalog Number | NGS-HD-01 |
| Company DUNS | 959181160 |
| Company Name | MRI INTERVENTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850359007034 [Primary] |
FDA Product Code
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-12 |
Devices Manufactured by MRI INTERVENTIONS, INC.
| 00850359007042 - SmartFlow | 2019-03-21 Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 4 ft x 15mm tip |
| 00850359007043 - SmartFlow | 2019-03-21 Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 10 ft x 15mm tip |
| 00850359007044 - SmartFlow | 2019-03-21 Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 4 ft x 15mm tip |
| 00850359007045 - SmartFlow | 2019-03-21 Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 10 ft x 15mm tip |
| 00850359007046 - SmartFlow | 2019-03-21 Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 12mm tip |
| 00850359007047 - SmartFlow | 2019-03-21 Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 10mm tip |
| 00850359007048 - Smartflow | 2019-03-21 Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip |
| 00850359007049 - SmartFlow | 2019-03-21 Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip (short) |
Trademark Results [SmartTwist]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTTWIST 85932641 4512579 Live/Registered |
MRI Interventions, Inc. 2013-05-15 |
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