DISP DYNAMIC REFERENCE FRAME

GUDID 00815212022944

Izi Medical Products, LLC

Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00815212022944
• NIH Device Record Key: 66eba437-0faa-4a5c-bbb6-1db0892ad202
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISP DYNAMIC REFERENCE FRAME
• Version Model Number: MP2000-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	00815212022944 [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: 2017-01-25

On-Brand Devices [DISP DYNAMIC REFERENCE FRAME ]

• 00815212022944: MP2000-CM
• 00815212022913: MP2000