OSTEOPAL® 66031896

GUDID 04260102130326

Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from powder and liquid by exothermic polymerization

Heraeus Medical GmbH

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 04260102130326
• NIH Device Record Key: ce596653-402c-44ef-a9ff-7bf008216078
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTEOPAL®
• Version Model Number: V
• Catalog Number: 66031896
• Company DUNS: 333623937
• Company Name: Heraeus Medical GmbH
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260102130326 [Package]; Contains: 04260102130494; Package: Carton [20 Units]; In Commercial Distribution
GS1	04260102130494 [Primary]
GS1	04260102132283 [Package]; Contains: 04260102130494; Package: Pallet [400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050085

FDA Product Code

• LOD: Bone Cement

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: 2020-08-18
• Device Publish Date: 2020-08-10

On-Brand Devices [OSTEOPAL®]

• 04260102132603: OSTEOPAL® plus is a radiopaque, low-viscosity bone cement, based on polymethyl methacrylate wit
• 04260102130326: Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from p