Osteo-site Bone Filler Kit-MV

GUDID 00815212026805

Izi Medical Products, LLC

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 00815212026805
• NIH Device Record Key: ee0c7cc2-bcc2-4487-a38d-952377a984f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteo-site Bone Filler Kit-MV
• Version Model Number: G80011
• 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	00815212026805 [Primary]

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

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: 2024-02-26
• Device Publish Date: 2024-02-16

On-Brand Devices [Osteo-site Bone Filler Kit-MV]

• 00815212026805: G80011
• 00815212026799: G80010