SmartTip NGS-DB-45-S
GUDID 00850359007959
SmartTip MR Short Drill Bit Kit
CLEARPOINT NEURO, INC.
Fluted surgical drill bit, single-use| Primary Device ID | 00850359007959 |
| NIH Device Record Key | a41f4ae6-6789-40f9-84a5-d12de8308ad3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartTip |
| Version Model Number | NGS-DB-45-S |
| Catalog Number | NGS-DB-45-S |
| Company DUNS | 959181160 |
| Company Name | CLEARPOINT NEURO, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
| Outer Diameter | 4.5 Millimeter |
| Length | 6.75 Inch |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850359007959 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160129
FDA Product Code
| HBG | Drills, Burrs, Trephines & Accessories (Manual) |
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-15 |
| Device Publish Date | 2021-04-07 |
On-Brand Devices [SmartTip]
| 08503590070368 | SmartTip MRII Drill Kit, 4.5 mm |
| 08503590070351 | SmartTip MRII Drill Kit, 3.2-mm |
| 00850359007362 | SmartTip MRII Drill Kit, 4.5 mm |
| 00850359007355 | SmartTip MRII Drill Kit, 3.2-mm |
| 00850359007959 | SmartTip MR Short Drill Bit Kit |
Trademark Results [SmartTip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTTIP 97912498 not registered Live/Pending |
ComeBack Mobility, Inc. 2023-04-28 |
 SMARTTIP 90453287 not registered Live/Pending |
Graco Minnesota Inc. 2021-01-07 |
 SMARTTIP 90005406 not registered Live/Pending |
Olympus Corporation 2020-06-17 |
 SMARTTIP 86470543 not registered Dead/Abandoned |
Banos, Juan 2014-12-03 |
 SMARTTIP 85932647 4512580 Live/Registered |
MRI Interventions, Inc. 2013-05-15 |
 SMARTTIP 78364165 2956150 Dead/Cancelled |
Comarco Wireless Technologies, Inc. 2004-02-06 |
 SMARTTIP 77128043 3799914 Live/Registered |
Olympus Corporation 2007-03-12 |
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