Osartis G M B H

FDA Filings

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.

FDA Registration(s)
Registration Number9615014
FEI Number3005568854
NameChristine L. Brauer
Owner & OperatorOSARTIS GmbH
Contact AddressLagerstrasse 11-15
Dieburg DE-HE Hessen 64807 DE
Official Correspondent
  • Volker Stirnal
  • 49-6071-929-220
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7 Trail House Court
Rockville, MD 20850 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
OSARTIS GmbH
 BonOs HV Genta 01-02622024-04-11
OSARTIS GmbH
 EASYMIX® Nozzle revision 02-01052022-12-09
OSARTIS GmbH
 EASYMIX® Nozzle slim 02-01042022-12-09
OSARTIS GmbH
 EASYMIX® vacuum pump II 02-02012022-12-09
OSARTIS GmbH
 EASYMIX® vacuum pump I 02-04012022-12-09
OSARTIS GmbH
 EASYMIX® compressed air hose 02-02062022-12-09
OSARTIS GmbH
 EASYMIX® compressed air hose 02-02052022-12-09
OSARTIS GmbH
 EASYMIX cement injector 02-0504-042022-12-06
OSARTIS GmbH
 EASYMIX pro 02-03052021-11-19
OSARTIS GmbH
 ManuMix 02-06022021-10-20
OSARTIS GmbH
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta2021-03-19
Osartis GmbH
BonOs HV, BonOs MV, BonOs LV2021-03-19
OSARTIS GmbH
 Simplex HV with Gentamicin 6195-1-0102020-02-14
OSARTIS GmbH
 Simplex HV 6194-1-0102020-02-14
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 08.702.017S2020-02-14
OSARTIS GmbH
Hi-Fatigue Bone Cement2019-12-02
OSARTIS GmbH
Hi-Fatigue G Bone Cement2019-11-27
Christine L. Brauer [OSARTIS GmbH]
Traumacem V+ Injectable Bone Cement2017-11-07
Christine L. Brauer [OSARTIS GmbH]
BonOs R2017-05-29
Christine L. Brauer [OSARTIS GmbH]
BonOs R Genta2017-05-29
Christine L. Brauer [OSARTIS GmbH]
BonOs R Genta2017-05-29
Christine L. Brauer [OSARTIS GmbH]
Vertecem II Mixing Kit2017-05-29
Christine L. Brauer [OSARTIS GmbH]
Vertecem II Mixing Kit2017-05-29
Christine L. Brauer [OSARTIS GmbH]
BonOs Inject2017-05-29
Christine L. Brauer [OSARTIS GmbH]
Versabond2017-05-29
Christine L. Brauer [OSARTIS GmbH]
Versabond AB2017-05-29
Christine L. Brauer [OSARTIS GmbH]
Versabond AB2017-05-29
Christine L. Brauer [OSARTIS GmbH]
MixOR2017-05-29

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020081546626Bremerhaven,Federal Republic of Germany -> Houston, TexasEXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 256 FIBREBOARD BOXES PACKED ON 11 PALLETS256 PKG
20200613494Bremerhaven,Federal Republic of Germany -> Houston, TexasEXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 498 FIBREBOARD BOXES PACKED ON 21 PALLETS498 PKG
20200523168Bremerhaven,Federal Republic of Germany -> Houston, TexasEXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 498 FIBREBOARD BOXES PACKED ON 21 PALLETS498 PKG
202005082935Bremerhaven,Federal Republic of Germany -> Houston, TexasEXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 254 FIBREBOARD BOXES PACKED ON 11 PALLETS254 PKG
2020042036378Bremerhaven,Federal Republic of Germany -> Houston, TexasEXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 254 FIBREBOARD BOXES PACKED ON 11 PALLETS254 PKG
2020040317707Bremerhaven,Federal Republic of Germany -> Houston, TexasEXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 256 FIBREBOARD BOXES PACKED ON 11 PALLETS256 PKG
2020040214760Bremerhaven,Federal Republic of Germany -> Houston, TexasEXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 256 FIBREBOARD BOXES PACKED ON 11 PALLETS256 PKG
2020033024092Bremerhaven,Federal Republic of Germany -> Houston, TexasEXCEPTED QUANTITIES - COBALT HV GENTA BONE CEMENT HS CODE 300640 UN1247 CLASS 3 256 FIBREBOARD BOXES PACKED ON 11 PALLETS256 PKG
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