PALACOS 00-1112-140-01

GUDID B578001112140011

PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS ® R contains the X-ray contrast medium zirconium dioxide

Heraeus Medical GmbH

Orthopaedic cement, non-medicated

• Primary Device ID: B578001112140011
• NIH Device Record Key: 1d7768b2-3b2e-4735-b94a-ba678bd7d1f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALACOS
• Version Model Number: R
• Catalog Number: 00-1112-140-01
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B578001112140011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030902

FDA Product Code

• LOD: Bone Cement

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-01

On-Brand Devices [PALACOS]

• B5780011191400115: PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It con
• B5780011181400114: PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOSÂ
• B578001113140011: PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing o
• B578001112140011: PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS Â