SmartFrame NGS-XG-02
GUDID 00850359007317
SmartFrame® XG Exchangeable Device Guide, 4.5-mm
CLEARPOINT NEURO, INC.
Manual cranial rotary handpiece, single-use| Primary Device ID | 00850359007317 |
| NIH Device Record Key | c4447214-4447-441e-8a59-0f5b8d5b8956 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartFrame |
| Version Model Number | NGS-XG-02 |
| Catalog Number | NGS-XG-02 |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Lumen/Inner Diameter | 4.5 Millimeter |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850359007317 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200079
FDA Product Code
| HAW | Neurological Stereotaxic Instrument |
| 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 | 2021-02-01 |
| Device Publish Date | 2021-01-22 |
On-Brand Devices [SmartFrame]
| 08503590070412 | SMARTFrame Scalp Mount Rescue Screw- Short |
| 08503590070405 | SMARTFrame Scalp Mount Rescue Screw - Long |
| 08503590070399 | SMARTFrame Skull Mount Rescue Screw |
| 08503590070382 | SMARTFrame Wharen Centering Guide |
| 08503590070337 | SmartFrame® Skull Mount Base |
| 08503590070320 | SMARTFrame Scalp Mount Base |
| 08503590070313 | SmartFrame® XG Exchangeable Device Guide, 4.5-mm |
| 08503590070306 | SMARTFrame XG Exchangeable Device Guides |
| 08503590070283 | SMARTFrame Guide Tubes .074” / 15 ga |
| 08503590070276 | SMARTFrame Guide Tubes .068” / 16 ga |
| 08503590070269 | SMARTFrame Guide Tubes .064” / CP Stylet |
| 08503590070252 | SMARTFrame Guide Tubes .060” / 17 ga |
| 08503590070245 | SMARTFrame Guide Tubes .052” / 18 ga |
| 08503590070238 | SMARTFrame Guide Tubes |
| 08503590070177 | SMARTFrame Thumb Wheel Extension Set |
| 08503590070160 | SMARTFrame Hand Controller |
| 08503590070153 | SMARTFrame Accessory Kit |
| 08503590070139 | SMARTFrame MRI-Guided Trajectory Tower w/o Base |
| 08503590070122 | SMARTFrame XG MRI-Guided Trajectory Frame |
| 08503590070115 | SMARTFrame MRI-Guided Trajectory Frame |
| 08503590070108 | SMARTFrame XG 4.5 w/ Wharen Centering Guide and TE |
| 08503590070092 | SMARTFrame XG 4.5 TwistPoint Kit w/ TE |
| 08503590070085 | SMARTFrame XG 4.5 TwistPoint Kit w/ HC |
| 08503590070078 | SMARTFrame XG TwistPoint Kit w/ HC - E |
| 08503590070054 | SMARTFrame XG TwistPoint Kit w/ HC |
| 08503590070047 | SMARTFrame Scalp Mount Kit w/ TE |
| 08503590070030 | SMARTFrame Scalp Mount Kit w/ HC |
| 08503590070023 | SMARTFrame Kit w/ TE |
| 08503590070016 | SMARTFrame Kit w/ HC |
| 00850359007416 | SMARTFrame Scalp Mount Rescue Screw- Short |
| 00850359007409 | SMARTFrame Scalp Mount Rescue Screw - Long |
| 00850359007393 | SMARTFrame Skull Mount Rescue Screw |
| 00850359007386 | SMARTFrame Wharen Centering Guide |
| 00850359007331 | SmartFrame® Skull Mount Base |
| 00850359007324 | SMARTFrame Scalp Mount Base |
| 00850359007317 | SmartFrame® XG Exchangeable Device Guide, 4.5-mm |
| 00850359007300 | SMARTFrame XG Exchangeable Device Guides |
| 00850359007287 | SMARTFrame Guide Tubes .074” / 15 ga |
| 00850359007270 | SMARTFrame Guide Tubes .068” / 16 ga |
| 00850359007263 | SMARTFrame Guide Tubes .064” / CP Stylet |
| 00850359007256 | SMARTFrame Guide Tubes .060” / 17 ga |
| 00850359007249 | SMARTFrame Guide Tubes .052” / 18 ga |
| 00850359007232 | SMARTFrame Guide Tubes |
| 00850359007171 | SMARTFrame Thumb Wheel Extension Set |
| 00850359007164 | SMARTFrame Hand Controller |
| 00850359007157 | SMARTFrame Accessory Kit |
| 00850359007133 | SMARTFrame MRI-Guided Trajectory Tower w/o Base |
| 00850359007126 | SMARTFrame XG MRI-Guided Trajectory Frame |
| 00850359007119 | SMARTFrame MRI-Guided Trajectory Frame |
| 00850359007102 | SMARTFrame XG 4.5 w/ Wharen Centering Guide and TE |
Trademark Results [SmartFrame]
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