ShadowForm Marker

GUDID 00815212021695

Izi Medical Products, LLC

Radiographic image marker, manual

• Primary Device ID: 00815212021695
• NIH Device Record Key: 7fc37de6-cd26-4ee0-8b2f-2bcd8a7689c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShadowForm Marker
• Version Model Number: VIP1710
• 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: false
• 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	00815212021695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964972

FDA Product Code

• KPQ: System, Simulation, Radiation Therapy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-17

On-Brand Devices [ShadowForm Marker]

• 00815212022074: S-SF5003
• 00815212022067: S-SF5002
• 00815212022050: S-SF5001
• 00815212021749: SF5003
• 00815212021732: SF5002
• 00815212021725: SF5001
• 00815212021718: VIP1740
• 00815212021701: VIP1735
• 00815212021695: VIP1710