Navigated Brain Biopsy Cannula

GUDID 00815212020315

Navigated Brain Biopsy Cannula - Compatible BrainLab

Izi Medical Products, LLC

Brain biopsy procedure kit

• Primary Device ID: 00815212020315
• NIH Device Record Key: e7790415-7414-4fe1-bb3a-b4041daf4103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated Brain Biopsy Cannula
• Version Model Number: BL3010
• Company DUNS: 933506164
• Company Name: Izi Medical Products, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815212020315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140705

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: 2020-06-11
• Device Publish Date: 2020-06-03

On-Brand Devices [Navigated Brain Biopsy Cannula ]

• 00815212020315: Navigated Brain Biopsy Cannula - Compatible BrainLab
• 00815212020308: Navigated Brain Biopsy Cannula - Compatible Brainlab
• 00815212020292: Navigated Brain Biopsy Cannula - Compatible Brainlab
• 00815212020285: Navigate Brain Biopsy Cannula - Compatible BrainLab