SmartFrame XG Exchangeable Drill Guide-6.0 mm NGS-XG-05

GUDID 08503590070870

A Device Guide used with SmartFrame XG that accepts ~6.0 mm drill bits

CLEARPOINT NEURO, INC.

Manual cranial rotary handpiece, single-use

• Primary Device ID: 08503590070870
• NIH Device Record Key: 195785e6-3a20-491f-84ea-e9c795953e4c
• Commercial Distribution Discontinuation: 2035-04-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartFrame XG Exchangeable Drill Guide-6.0 mm
• Version Model Number: NGS-XG-05
• Catalog Number: NGS-XG-05
• 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: 9499006833
• Email: customerservice@clearpointneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08503590070870 [Primary]

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

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: 2020-06-30
• Device Publish Date: 2020-06-22

On-Brand Devices [SmartFrame XG Exchangeable Drill Guide-6.0 mm]

• 08503590070870: A Device Guide used with SmartFrame XG that accepts ~6.0 mm drill bits
• 00850359007874: A Device Guide used with SmartFrame XG that accepts ~6.0 mm drill bits