Simplex HV with Gentamicin 6195-1-010

GUDID 24260056885765

Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.

OSARTIS GmbH

Orthopaedic cement, medicated

• Primary Device ID: 24260056885765
• NIH Device Record Key: fecad468-9d2e-4241-80de-6c548421c6f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simplex HV with Gentamicin
• Version Model Number: 6195-1-001
• Catalog Number: 6195-1-010
• Company DUNS: 344261631
• Company Name: OSARTIS 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 Dimensions

• Weight: 40.8 Gram
• Weight: 40.8 Gram

Operating and Storage Conditions

• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260056885761 [Primary]
GS1	14260056885768 [Package]; Contains: 04260056885761; Package: Dispenser box [10 Units]; In Commercial Distribution
GS1	24260056885765 [Package]; Contains: 14260056885768; Package: Shipping unit [2 Units]; In Commercial Distribution

FDA Product Code

• MBB: Bone Cement, Antibiotic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-14
• Device Publish Date: 2015-09-24

Devices Manufactured by OSARTIS GmbH

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• 04260056881633 - EASYMIX® vacuum pump I: 2022-12-09 The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with c
• 04260056881930 - EASYMIX® vacuum pump II: 2022-12-09 The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with c