SmartTip NGS-DB-01

GUDID 00850359007035

SmartTip MRII Drill Kit, 3.2-mm

MRI INTERVENTIONS, INC.

Fluted surgical drill bit, single-use, sterile

• Primary Device ID: 00850359007035
• NIH Device Record Key: f1f1c2db-9d8e-4f6e-8669-c43661d9783e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartTip
• Version Model Number: NGS-DB-01
• Catalog Number: NGS-DB-01
• Company DUNS: 959181160
• Company Name: MRI INTERVENTIONS, 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: info@mriinterventions.com

Device Dimensions

• Outer Diameter: 3.2 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850359007035 [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: 3
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-08-12

On-Brand Devices [SmartTip]

• 00850359007036: SmartTip MRII Drill Kit, 4.5 mm
• 00850359007035: SmartTip MRII Drill Kit, 3.2-mm