STRYKER NAVIGATED BIOPSY NEEDLE

GUDID 00815212024467

Izi Medical Products, LLC

Brain biopsy procedure kit

• Primary Device ID: 00815212024467
• NIH Device Record Key: aa6d34de-b1c1-4949-8995-6612b9d5b747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRYKER NAVIGATED BIOPSY NEEDLE
• Version Model Number: 6000-805-800
• 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: true
• 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	00815212024467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143241

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: 2024-08-07
• Device Publish Date: 2024-07-30

Devices Manufactured by Izi Medical Products, LLC

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• 00815212026904 - OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10G: 2024-08-13
• 00815212024467 - STRYKER NAVIGATED BIOPSY NEEDLE: 2024-08-07
• 00815212024467 - STRYKER NAVIGATED BIOPSY NEEDLE: 2024-08-07
• 00815212026874 - BKP-10-12.0-15.0-A: 2024-07-08
• 00815212026881 - BKP-11-12.0-15.0-A: 2024-07-08
• 00815212026867 - MDT NAVIGATED BIOPSY, COMPATIABLE 7D: 2024-03-26
• 00815212026812 - ONPOINT NAVIGATION KIT: 2024-03-06
• 00815212026829 - ONPOINT NAVIGATION TRAY: 2024-03-06