PALACOS® 5087347

GUDID 04260102136601

PALACOS® MV is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. PALACOS® MV contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® MV has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.

Heraeus Medical GmbH

Orthopaedic cement, non-medicated

• Primary Device ID: 04260102136601
• NIH Device Record Key: c0833eb3-4cf1-44dd-a8e8-ae19b8aafb67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALACOS®
• Version Model Number: MV
• Catalog Number: 5087347
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260102136601 [Primary]
GS1	04260102136618 [Package]; Package: Carton [20 Units]; In Commercial Distribution
GS1	04260102136625 [Package]; Package: Palette [400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182260

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: 6
• Public Version Date: 2019-05-09
• Device Publish Date: 2018-11-16

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®