PALACOS® 66057601

GUDID 04260102136083

PALACOS® fastR+G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The antibiotic gentamicin sulphate has been added to protect the cured cement and contiguous tissue against contamination by microbes sensitive to gentamicin. PALACOS® fastR+G is available in 51 g packaging size. PALACOS® fast R+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

Heraeus Medical GmbH

Orthopaedic cement, medicated

• Primary Device ID: 04260102136083
• NIH Device Record Key: a670929f-5690-48a9-8d42-a7341bdc61b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALACOS®
• Version Model Number: fast R+G
• Catalog Number: 66057601
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260102136069 [Primary]
GS1	04260102136076 [Package]; Contains: 04260102136069; Package: Carton [12 Units]; In Commercial Distribution
GS1	04260102136083 [Package]; Contains: 04260102136069; Package: Pallet [240 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190766

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: 2019-06-21
• Device Publish Date: 2019-06-13

On-Brand Devices [PALACOS®]

• 04260102136601: PALACOS® MV is intended for use in arthroplastic procedures of the hip, knee, and other joints
• 04260102136007: The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOSÂ
• 04260102135970: The PALACOS® R pro system consists of a mixing and application system prefilled with PALACOS®
• 04260102135857: PALACOS® MV is intended for use in arthroplastic procedures of the hip, knee, and other joints
• 04260102135826: PALACOS® MV+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee a
• 04260102135598: PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It con
• 04260102135567: PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOSÂ
• 04260102135536: PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing o
• 04260102135505: PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS Â
• 04260102136083: PALACOS® fastR+G is an acrylic bone cement for use in orthopedic surgery. It is formed from pow
• 04260102136281: The PALACOS® MV+G pro system consists of a mixing and application system prefilled with PALACOS
• 04260102136250: The PALACOS® MV+G pro system consists of a mixing and application system prefilled with PALACOS
• 04260102136229: The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOSÂ
• 04260102136199: The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOSÂ
• 04260102136168: The PALACOS® R pro system consists of a mixing and application system prefilled with PALACOS®
• 04260102136120: The PALACOS® R pro system consists of a mixing and application system prefilled with PALACOS®
• 04260102135376: The PALACOS® MV pro system consists of a mixing and application system prefilled with PALACOS®
• 04260102135338: The PALACOS® MV pro system consists of a mixing and application system prefilled with PALACOS®