SmartFrame NGS-SF-04-11

GUDID 00850376007758

SMARTFrame XG MRI-Guided Trajectory Frame w/o Base

CLEARPOINT NEURO, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00850376007758
• NIH Device Record Key: 341f6d91-caa5-42ba-8519-bc7986d8a7f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartFrame
• Version Model Number: NGS-SF-04-11
• Catalog Number: NGS-SF-04-11
• 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: true
• 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

• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com
• Phone: 949-900-6833
• Email: quality@clearpointneuro.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850376007758 [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: 2022-02-08
• Device Publish Date: 2022-01-31

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