Guerbet L L C

FDA Filings

This page includes the latest FDA filings for Guerbet L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Guerbet L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1518293
FEI Number1518293
NameLiebel-Flarsheim Company LLC
Owner & OperatorGuerbet LLC
Contact Address821 Alexander Ave Suite 204
Princeton NJ 08540 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2111 EAST GALBRAITH RD.
Cincinnati, OH 45237 US
Establishment Type
  • Manufacture Medical Device
  • Remanufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



Registration Number3007199309
FEI Number3007199309
NameGuerbet
Owner & OperatorGuerbet LLC
Contact Address821 Alexander Ave Suite 204
Princeton NJ 08540 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address16 rue Gay Lussac
Gonesse Val-dOise, 95500 FR
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



Registration Number3002859087
FEI Number3002859087
NameAlice Lorenzo
Owner & OperatorGuerbet LLC
Contact Address821 Alexander Ave Suite 204
Princeton NJ 08540 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address821 Alexander Rd Ste 204
Princeton, NJ 08540 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3012465398
FEI Number3012465398
NameLIEBEL-FLARSHEIM COMPANY LLC
Owner & OperatorGuerbet LLC
Contact Address821 Alexander Ave Suite 204
Princeton NJ 08540 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1034 S Brentwood Blvd
Richmond Heights, MO 63117 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2024-07-30
Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2024-02-21
Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2024-02-21
Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet
Prescription Medication2024-02-08
Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2023-12-29
Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet
Prescription Medication2023-12-29
Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2023-12-29
Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS
Prescription Medication2023-04-20
Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2023-01-11
Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS
Prescription Medication2022-12-06
Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet
Prescription Medication2022-11-10
Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet
Prescription Medication2022-10-27
Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet
Prescription Medication2022-10-14
Guerbet LLC
ELUCIREM2022-09-21
Guerbet LLC
ELUCIREM2022-09-21
Guerbet LLC
ELUCIREM2022-09-21
Guerbet LLC
ELUCIREM2022-09-21
Guerbet LLC
ELUCIREM2022-09-21
Guerbet LLC
ELUCIREM2022-09-21
Guerbet LLC
ELUCIREM2022-09-21
Guerbet LLC
ELUCIREM2022-09-21
Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS
Prescription Medication2021-12-22
Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS
Prescription Medication2020-06-24
Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2020-04-28
Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2020-04-22
Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS
Prescription Medication2020-01-18
Guerbet [Guerbet LLC]
Angiographic Syringe2019-11-19
Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2019-11-09
Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2019-11-09
Guerbet LLC
DOTAREM2019-09-18
Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2019-08-08
Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2019-06-01
Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2019-05-31
Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC
Prescription Medication2019-04-23
Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS
Prescription Medication2018-10-10
Guerbet LLC
2018-09-14
Alice Lorenzo [Guerbet LLC]
Monoject2018-01-14
LIEBEL-FLARSHEIM COMPANY LLC [Guerbet LLC]
DOTAject2016-12-22
LIEBEL-FLARSHEIM COMPANY LLC [Guerbet LLC]
HydraVision2016-06-20
Liebel-Flarsheim Company LLC [Guerbet LLC]
Remote stand2016-06-20
LIEBEL-FLARSHEIM COMPANY LLC [Guerbet LLC]
Remote stand2016-06-20
Alice Lorenzo [Guerbet LLC]
Monoject2015-11-11
Alice Lorenzo [Guerbet LLC]
Cardinal Health2015-11-11
Guerbet LLC
LIPIODOL2014-03-21
Guerbet LLC
DOTAREM2013-03-20
Guerbet LLC
DOTAREM2013-03-20

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CAGE Code3FM41GUERBET LLC
S.A.M. Registration3FM41 [37876096]GUERBET LLC
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019080347891Anvers,Belgium -> Charleston, South CarolinaGADOLINIUM OXIDE 4N LUM GUE75 PKG
2018061639686Anvers,Belgium -> New York, New YorkMEDECINES +20 CEL HS CODE 3006.30727 CTN
2018061639686Anvers,Belgium -> New York, New YorkMEDECINES +20 CEL HS CODE 3006.30727 CTN
2018050870002Le Havre,France -> New York/Newark Area, Newark, New JerseyMEDICAMENT +18CEL SCAC CODE DMAL LEH24682777 PLT
2018050870002Le Havre,France -> New York/Newark Area, Newark, New JerseyMEDICAMENT +18CEL LEH246827 SCAC CODE DMAL77 PLT
2018050870002Le Havre,France -> New York/Newark Area, Newark, New JerseyMEDICAMENT +18CEL SCAC CODE: DMAL LEH24682777 PLT
2018050870002Le Havre,France -> New York/Newark Area, Newark, New JerseyMEDICAMENT +18CEL SCAC CODE DMAL LEH24681777 PLT
2018033114432Le Havre,France -> New York/Newark Area, Newark, New JerseyMEDICAMENTS DOCTAREM + 18 CEL HS CODE : 3006.30 SCAC CODE DMAL LEH24594040 PLT
2018033114432Le Havre,France -> New York/Newark Area, Newark, New JerseyMEDICAMENTS DOCTAREM + 18 CEL HS CODE : 3006.30 SCAC CODE DMAL LEH24594040 PLT
2018032123716Le Havre,France -> New York/Newark Area, Newark, New JerseyMEDICAMENTS + 18 CEL19 PLT
2018031932049Le Havre,France -> New York/Newark Area, Newark, New JerseyMEDICAMENTS + 18 CEL19 PLT
2018030335386Le Havre,France -> New York/Newark Area, Newark, New JerseyPHARMACEUTICAL PRODUCT + 18 CEL HS CODE 3006.3019 PLT
2018021641274Anvers,Belgium -> New York/Newark Area, Newark, New JerseyMEDICAMENT DOTAREM55 PLT
2018021641274Anvers,Belgium -> New York/Newark Area, Newark, New JerseyMEDICAMENT DOTAREM55 PLT
2018021641274Anvers,Belgium -> New York/Newark Area, Newark, New JerseyMEDICAMENT DOTAREM55 PLT

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