BonOs HV Genta 01-0262

GUDID 04260056882623

BonOs® HV Genta 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. BonOs® HV Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment.

OSARTIS GmbH

Orthopaedic cement, antimicrobial

• Primary Device ID: 04260056882623
• NIH Device Record Key: b635a1de-318d-43af-ae75-16eead8bc479
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BonOs HV Genta
• Version Model Number: 1x40
• Catalog Number: 01-0262
• 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
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram
• Weight: 40.8 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 25°C (77°F)
• Handling Environment Temperature: Between 17 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260056882623 [Primary]
GS1	14260056882620 [Package]; Package: Shipping unit [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210125

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: 2024-04-11
• Device Publish Date: 2024-04-03

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• 04260056882623 - BonOs HV Genta: 2024-04-11BonOs® HV Genta 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. BonOs® HV Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
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