PALACOS® 5051206

GUDID 04260102135857

PALACOS® MV is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic impl

Heraeus Medical GmbH

Orthopaedic cement, non-medicated

• Primary Device ID: 04260102135857
• NIH Device Record Key: 58dc29f1-b135-4c12-a723-0f133a178477
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALACOS®
• Version Model Number: MV
• Catalog Number: 5051206
• 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	04260102135857 [Primary]
GS1	04260102135864 [Package]; Package: [20 Units]; In Commercial Distribution
GS1	04260102135871 [Package]; Package: [400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030904

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: 5
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-03-16

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 PALACOS�
• 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. PALACOS�
• 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 �
• 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 PALACOS�
• 04260102136199: The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS�
• 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®