PALACOS® 5081288

GUDID 04260102136199

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

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• Primary Device ID: 04260102136199
• NIH Device Record Key: 28eb2ce9-39c2-4856-a864-7806a716d90f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALACOS®
• Version Model Number: R+G pro 40
• Catalog Number: 5081288
• 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: 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 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
• 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
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260102136182 [Primary]
GS1	04260102136199 [Package]; Contains: 04260102136182; Package: Paper Carton [6 Units]; In Commercial Distribution
GS1	04260102136205 [Package]; Contains: 04260102136182; Package: Pallet [144 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210607

FDA Product Code

• MBB: Bone Cement, Antibiotic

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: 2021-07-23
• Device Publish Date: 2021-07-15

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®