PALACOS 00-1113-140-01

GUDID B578001113140011

PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and

Heraeus Medical GmbH

Orthopaedic cement, non-medicated Orthopaedic cement, non-medicated

• Primary Device ID: B578001113140011
• NIH Device Record Key: 42fa90d7-50e6-4de6-8f84-8af85ee3fa80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALACOS
• Version Model Number: R+G
• Catalog Number: 00-1113-140-01
• 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: true
• 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	B578001113140011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031673

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

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• B5780011181400114: PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS�
• 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 �