MDT NAVIGATED BIOPSY, COMPATIABLE 7D

GUDID 00815212026867

Izi Medical Products, LLC

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• Primary Device ID: 00815212026867
• NIH Device Record Key: 665cd052-68c6-48d8-8fc0-05b1b0031a5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDT NAVIGATED BIOPSY, COMPATIABLE 7D
• Version Model Number: MB3000-7D-I
• Company DUNS: 933506164
• Company Name: Izi Medical Products, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00815212026867 [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: 2024-03-26
• Device Publish Date: 2024-03-18

Devices Manufactured by Izi Medical Products, LLC

• 00815212026867 - MDT NAVIGATED BIOPSY, COMPATIABLE 7D: 2024-03-26
• 00815212026867 - MDT NAVIGATED BIOPSY, COMPATIABLE 7D: 2024-03-26
• 00815212026812 - ONPOINT NAVIGATION KIT: 2024-03-06
• 00815212026829 - ONPOINT NAVIGATION TRAY: 2024-03-06
• 00815212026836 - ONPOINT SNAP SPHERZ 25PK: 2024-03-06
• 00815212026843 - ONPOINT SPHERZ PASSIVE MARKER-12 PACK: 2024-03-06
• 00815212026850 - ONPOINT PEDICLE ACCESS NEEDLE: 2024-03-06
• 10815212026819 - ONPOINT NAVIGATION 10 BOX: 2024-03-06
• 20815212026816 - ONPOINT NAVIGATION 25 BOXES: 2024-03-06