Disposable Passive Array - Blunt Probe

GUDID 00815212022180

Izi Medical Products, LLC

Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00815212022180
• NIH Device Record Key: 71839ab2-c8ed-4c1d-adbf-2ddc077f56b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Passive Array - Blunt Probe
• Version Model Number: MP1010-CM
• 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: 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	00815212022180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142344

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-26

On-Brand Devices [Disposable Passive Array - Blunt Probe]

• 00815212022180: MP1010-CM
• 00815212022173: MP1005-CM
• 00815212022166: MP1004-CM
• 00815212022159: MP1000-CM
• 00815212020391: MP1010
• 00815212020384: MP1005
• 00815212020377: MP1004
• 00815212020360: MP1000