This page includes the latest FDA filings for Osartis G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 9615014 |
| FEI Number | 3005568854 |
| Name | Christine L. Brauer |
| Owner & Operator | OSARTIS GmbH |
| Contact Address | Lagerstrasse 11-15 Dieburg DE-HE Hessen 64807 DE |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 7 Trail House Court Rockville, MD 20850 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| OSARTIS GmbH | BonOs HV 01-0162 | 2024-05-27 |
| OSARTIS GmbH | BonOs HV Genta 01-0262 | 2024-04-11 |
| OSARTIS GmbH | EASYMIX® Nozzle revision 02-0105 | 2022-12-09 |
| OSARTIS GmbH | EASYMIX® Nozzle slim 02-0104 | 2022-12-09 |
| OSARTIS GmbH | EASYMIX® vacuum pump II 02-0201 | 2022-12-09 |
| OSARTIS GmbH | EASYMIX® vacuum pump I 02-0401 | 2022-12-09 |
| OSARTIS GmbH | EASYMIX® compressed air hose 02-0206 | 2022-12-09 |
| OSARTIS GmbH | EASYMIX® compressed air hose 02-0205 | 2022-12-09 |
| OSARTIS GmbH | EASYMIX cement injector 02-0504-04 | 2022-12-06 |
| OSARTIS GmbH | EASYMIX pro 02-0305 | 2021-11-19 |
| OSARTIS GmbH | ManuMix 02-0602 | 2021-10-20 |
OSARTIS GmbH | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | 2021-03-19 |
Osartis GmbH | BonOs HV, BonOs MV, BonOs LV | 2021-03-19 |
| OSARTIS GmbH | Simplex HV with Gentamicin 6195-1-010 | 2020-02-14 |
| OSARTIS GmbH | Simplex HV 6194-1-010 | 2020-02-14 |
| OSARTIS GmbH | BonOs R Genta 1x40 | 2020-02-14 |
| OSARTIS GmbH | BonOs R 1x40 | 2020-02-14 |
| OSARTIS GmbH | BonOs Inject | 2020-02-14 |
| OSARTIS GmbH | Vertecem II Cement Kit 08.702.017S | 2020-02-14 |
OSARTIS GmbH | Hi-Fatigue Bone Cement | 2019-12-02 |
OSARTIS GmbH | Hi-Fatigue G Bone Cement | 2019-11-27 |
Christine L. Brauer [OSARTIS GmbH] | Traumacem V+ Injectable Bone Cement | 2017-11-07 |
Christine L. Brauer [OSARTIS GmbH] | BonOs R | 2017-05-29 |
Christine L. Brauer [OSARTIS GmbH] | BonOs R Genta | 2017-05-29 |
Christine L. Brauer [OSARTIS GmbH] | BonOs R Genta | 2017-05-29 |
Christine L. Brauer [OSARTIS GmbH] | Vertecem II Mixing Kit | 2017-05-29 |
Christine L. Brauer [OSARTIS GmbH] | Vertecem II Mixing Kit | 2017-05-29 |
Christine L. Brauer [OSARTIS GmbH] | BonOs Inject | 2017-05-29 |
Christine L. Brauer [OSARTIS GmbH] | Versabond | 2017-05-29 |
Christine L. Brauer [OSARTIS GmbH] | Versabond AB | 2017-05-29 |
Christine L. Brauer [OSARTIS GmbH] | Versabond AB | 2017-05-29 |
Christine L. Brauer [OSARTIS GmbH] | MixOR | 2017-05-29 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020081546626 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | EXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 256 FIBREBOARD BOXES PACKED ON 11 PALLETS | 256 PKG |
| 20200613494 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | EXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 498 FIBREBOARD BOXES PACKED ON 21 PALLETS | 498 PKG |
| 20200523168 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | EXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 498 FIBREBOARD BOXES PACKED ON 21 PALLETS | 498 PKG |
| 202005082935 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | EXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 254 FIBREBOARD BOXES PACKED ON 11 PALLETS | 254 PKG |
| 2020042036378 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | EXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 254 FIBREBOARD BOXES PACKED ON 11 PALLETS | 254 PKG |
| 2020040317707 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | EXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 256 FIBREBOARD BOXES PACKED ON 11 PALLETS | 256 PKG |
| 2020040214760 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | EXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 256 FIBREBOARD BOXES PACKED ON 11 PALLETS | 256 PKG |
| 2020033024092 | Bremerhaven,Federal Republic of Germany -> Houston, Texas | EXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 256 FIBREBOARD BOXES PACKED ON 11 PALLETS | 256 PKG |