BonOs HV 01-0162

GUDID 04260056882579

BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant. BonOs® HV cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV does not emit a signal and does not pose a safety risk in a magnetic resonance environment.

OSARTIS GmbH

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 04260056882579
• NIH Device Record Key: 3faa9394-1921-4b52-8fe9-5f27a398d260
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BonOs HV
• Version Model Number: 1x40
• Catalog Number: 01-0162
• 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: 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

Device Dimensions

• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 Gram
• Weight: 40 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
• 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	04260056882579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210120

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: 2024-05-27
• Device Publish Date: 2024-05-17

Devices Manufactured by OSARTIS GmbH

• 04260056882579 - BonOs HV: 2024-05-27BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant. BonOs® HV cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
• 04260056882579 - BonOs HV: 2024-05-27 BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductil
• 04260056882623 - BonOs HV Genta: 2024-04-11 BonOs® HV Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two sep
• 14260056880619 - EASYMIX® Nozzle slim: 2022-12-09 The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing syst
• 14260056880916 - EASYMIX® Nozzle revision: 2022-12-09 The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing syst
• 04260056881022 - EASYMIX® compressed air hose: 2022-12-09 EASYMIX® compressed air hose, 5 m, Medap wall coupling. The compressed air hoses connect the EASYMIX® vacuum pump to the compr
• 04260056881039 - EASYMIX® compressed air hose: 2022-12-09 EASYMIX® compressed air hose, 5 m, DIN 13260-2 wall coupling. Compressed air hoses connect the EASYMIX® vacuum pump to the com
• 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