PALACOS® 5150635

GUDID 04260102135376

The PALACOS® MV pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® MV pro 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.

Heraeus Medical GmbH

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 04260102135376
• NIH Device Record Key: ba506936-bdc6-40d2-8427-875d4ec776c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALACOS®
• Version Model Number: MV pro 80
• Catalog Number: 5150635
• Company DUNS: 333623937
• Company Name: Heraeus Medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260102135369 [Primary]
GS1	04260102135376 [Package]; Contains: 04260102135369; Package: Paper Carton [6 Units]; In Commercial Distribution
GS1	04260102135383 [Package]; Contains: 04260102135369; Package: Pallet [144 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213812

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: 2022-02-21
• Device Publish Date: 2022-02-13

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®