Multi-Modality Markers

GUDID 10815212020268

Izi Medical Products, LLC

Radiological image marker, noninvasive, single-use

• Primary Device ID: 10815212020268
• NIH Device Record Key: de2020b2-92f8-419a-8438-1c56d5fb28f9
• Commercial Distribution Discontinuation: 2025-08-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Modality Markers
• Version Model Number: 960-991
• 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	10815212020268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014022

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-17
• Device Publish Date: 2016-11-03

On-Brand Devices [Multi-Modality Markers]

• 00815212022869: S-MM3005
• 00815212022845: S-MM3002
• 00815212022784: MM3005-VIP
• 00815212022777: MM3005CLM
• 00815212022753: REG3002
• 00815212020773: MM3007
• 00815212020766: MM3005
• 00815212020759: MM3003
• 00815212020742: MM3002-60
• 00815212020735: MM3002-10I
• 00815212020728: MM3002-100
• 00815212020711: MM3002-10
• 00815212020704: MM3002
• 00815212020278: 52160
• 00815212020261: 960-991
• 10815212020268: 960-991