| Primary Device ID | 14260056885676 |
| NIH Device Record Key | 4175c2fb-0500-48f5-869e-c15cc335e4a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BonOs R Genta 1x40 |
| Version Model Number | 01-0217 |
| 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 |
| Weight | 40.8 Gram |
| Handling Environment Temperature | Between 17 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 17 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260056885679 [Primary] |
| GS1 | 14260056885676 [Package] Contains: 04260056885679 Package: Shipping unit [20 Units] In Commercial Distribution |
| MBB | Bone Cement, Antibiotic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-14 |
| Device Publish Date | 2015-09-25 |
| 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 |
| 04260056881251 - EASYMIX cement injector | 2022-12-06 The cement injector is used to apply bone cements. It is operated manually and provides a secure environment for the cartridge a |