OSTEOPAL® 66045747

GUDID 04260102132603

OSTEOPAL® plus is a radiopaque, low-viscosity bone cement, based on polymethyl methacrylate with an extended application phase, used to fill and stabilize vertebral bodies. OSTEOPAL® plus contains zirconium dioxide as an X-ray contrast agent. OSTEOPAL® plus contains the coloring agent chlorophyll VIII (E141) to improve visibility in the surgical field. The bone cement is prepared immediately prior to use by mixing the polymer powder component and the liquid monomer component. A low viscosity paste is applied with the use of application system, placed in the vertebral body, where it cures. OSTEOPAL® plus conforms to ISO 5833 except Annex C

Heraeus Medical GmbH

Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial Orthopaedic cement, non-antimicrobial

• Primary Device ID: 04260102132603
• NIH Device Record Key: d901af8b-7469-4824-8a68-eb3646fd8d01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSTEOPAL®
• Version Model Number: plus
• Catalog Number: 66045747
• 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	04260102132597 [Primary]
GS1	04260102132603 [Package]; Contains: 04260102132597; Package: Carton [20 Units]; In Commercial Distribution
GS1	04260102132788 [Package]; Contains: 04260102132597; Package: Pallet [400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153737

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