ClearPoint PURSUIT MCA-53-250

GUDID 08503590070689

MR Compatible Aspiration Kit, 5.3 mm OD x 250 mm Length

CLEARPOINT NEURO, INC.

General-purpose endoscopic needle, single-use

• Primary Device ID: 08503590070689
• NIH Device Record Key: 3d4aab93-cceb-4b8d-b6e8-74e45ef0734c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearPoint PURSUIT
• Version Model Number: MCA-53-250
• Catalog Number: MCA-53-250
• Company DUNS: 959181160
• Company Name: CLEARPOINT NEURO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9499006833
• Email: info@mriinterventions.com

Device Dimensions

• Outer Diameter: 5.3 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08503590070689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181731

FDA Product Code

• GWG: Endoscope, Neurological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-12
• Device Publish Date: 2018-12-21

On-Brand Devices [ClearPoint PURSUIT]

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• 08503590070719: MCA Kit, 6.6 mm OD x 300 mm Length
• 08503590070702: MCA Kit, 5.9 mm OD x 250 mm Length
• 08503590070696: MCA Kit, 5.9 mm OD x 300 mm Length
• 08503590070689: MR Compatible Aspiration Kit, 5.3 mm OD x 250 mm Length
• 08503590070672: MR Compatible Aspiration Kit, 5.3 mm OD x 300 mm Length
• 00850359007720: MCA Kit, 6.6 mm OD x 250 mm Length
• 00850359007713: MCA Kit, 6.6 mm OD x 300 mm Length
• 00850359007706: MCA Kit, 5.9 mm OD x 250 mm Length
• 00850359007690: MCA Kit, 5.9 mm OD x 300 mm Length
• 00850359007683: MR Compatible Aspiration Kit, 5.3 mm OD x 250 mm Length
• 00850359007676: MR Compatible Aspiration Kit, 5.3 mm OD x 300 mm Length