ClearPoint CP-FFSMPL-02

GUDID 08503760070396

ClearPoint Multi-Positional Lower HFF Screws for Philips

CLEARPOINT NEURO, INC.

Stationary liquid oxygen container

• Primary Device ID: 08503760070396
• NIH Device Record Key: 75422cea-da62-4f91-a7a3-da3c562f904d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearPoint
• Version Model Number: CP-FFSMPL-02
• Catalog Number: CP-FFSMPL-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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: nfo@mriinterventions.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08503760070396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091439

FDA Product Code

• HBL: Holder, Head, Neurosurgical (Skull Clamp)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-03-12
• Device Publish Date: 2016-08-12

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