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:
| Registration Number | 1518293 |
| FEI Number | 1518293 |
| Name | Liebel-Flarsheim Company LLC |
| Owner & Operator | Guerbet LLC |
| Contact Address | 821 Alexander Ave Suite 204 Princeton NJ 08540 US |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2111 EAST GALBRAITH RD. Cincinnati, OH 45237 US |
| Establishment Type |
|
| Registration Number | 3007199309 |
| FEI Number | 3007199309 |
| Name | Guerbet |
| Owner & Operator | Guerbet LLC |
| Contact Address | 821 Alexander Ave Suite 204 Princeton NJ 08540 US |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 16 rue Gay Lussac Gonesse Val-dOise, 95500 FR |
| Establishment Type | Export Device to the United States But Perform No Other Operation on Device |
| Registration Number | 3002859087 |
| FEI Number | 3002859087 |
| Name | Alice Lorenzo |
| Owner & Operator | Guerbet LLC |
| Contact Address | 821 Alexander Ave Suite 204 Princeton NJ 08540 US |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 821 Alexander Rd Ste 204 Princeton, NJ 08540 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Registration Number | 3012465398 |
| FEI Number | 3012465398 |
| Name | LIEBEL-FLARSHEIM COMPANY LLC |
| Owner & Operator | Guerbet LLC |
| Contact Address | 821 Alexander Ave Suite 204 Princeton NJ 08540 US |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1034 S Brentwood Blvd Richmond Heights, MO 63117 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet | Prescription Medication | 2025-11-21 |
| Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2025-03-21 |
| Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2025-03-21 |
| Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet | Prescription Medication | 2025-03-11 |
| Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS | Prescription Medication | 2025-01-01 |
| Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2024-12-28 |
| Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet | Prescription Medication | 2024-12-28 |
| Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2024-12-28 |
| Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2024-07-30 |
| Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2024-02-21 |
| Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2024-02-21 |
| Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet | Prescription Medication | 2024-02-08 |
| Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2023-12-29 |
| Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet | Prescription Medication | 2023-12-29 |
| Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2023-12-29 |
| Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS | Prescription Medication | 2023-04-20 |
| Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2023-01-11 |
| Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS | Prescription Medication | 2022-12-06 |
| Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet | Prescription Medication | 2022-11-10 |
| Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet | Prescription Medication | 2022-10-27 |
| Guerbet LLC, Liebel-Flarsheim Company LLC, Guerbet | Prescription Medication | 2022-10-14 |
| Guerbet LLC | ELUCIREM | 2022-09-21 |
| Guerbet LLC | ELUCIREM | 2022-09-21 |
| Guerbet LLC | ELUCIREM | 2022-09-21 |
| Guerbet LLC | ELUCIREM | 2022-09-21 |
| Guerbet LLC | ELUCIREM | 2022-09-21 |
| Guerbet LLC | ELUCIREM | 2022-09-21 |
| Guerbet LLC | ELUCIREM | 2022-09-21 |
| Guerbet LLC | ELUCIREM | 2022-09-21 |
| Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS | Prescription Medication | 2021-12-22 |
| Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS | Prescription Medication | 2020-06-24 |
| Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2020-04-28 |
| Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2020-04-22 |
| Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS | Prescription Medication | 2020-01-18 |
Guerbet [Guerbet LLC] | Angiographic Syringe | 2019-11-19 |
| Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2019-11-09 |
| Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2019-11-09 |
| Guerbet LLC | DOTAREM | 2019-09-18 |
| Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2019-08-08 |
| Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2019-06-01 |
| Guerbet LLC, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2019-05-31 |
| Guerbet LLC, Catalent, Belgium, Recipharm Monts, Simafex, PCAS Finland O.y, Liebel-Flarsheim Company LLC | Prescription Medication | 2019-04-23 |
| Guerbet LLC, Simafex, Jubilant HollisterStier General Partnership, RECIPHARM MONTS, IFTS | Prescription Medication | 2018-10-10 |
| Guerbet LLC | 2018-09-14 | |
Alice Lorenzo [Guerbet LLC] | Monoject | 2018-01-14 |
LIEBEL-FLARSHEIM COMPANY LLC [Guerbet LLC] | DOTAject | 2016-12-22 |
LIEBEL-FLARSHEIM COMPANY LLC [Guerbet LLC] | HydraVision | 2016-06-20 |
Liebel-Flarsheim Company LLC [Guerbet LLC] | Remote stand | 2016-06-20 |
LIEBEL-FLARSHEIM COMPANY LLC [Guerbet LLC] | Remote stand | 2016-06-20 |
Alice Lorenzo [Guerbet LLC] | Monoject | 2015-11-11 |
Alice Lorenzo [Guerbet LLC] | Cardinal Health | 2015-11-11 |
| Guerbet LLC | LIPIODOL | 2014-03-21 |
| Guerbet LLC | DOTAREM | 2013-03-20 |
| Guerbet LLC | DOTAREM | 2013-03-20 |
| NCAGE Code | 3FM41 | GUERBET LLC |
| CAGE Code | 3FM41 | GUERBET LLC |
| S.A.M. Registration | 3FM41 [37876096] | GUERBET LLC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2019080347891 | Anvers,Belgium -> Charleston, South Carolina | GADOLINIUM OXIDE 4N LUM GUE | 75 PKG |
| 2018061639686 | Anvers,Belgium -> New York, New York | MEDECINES +20 CEL HS CODE 3006.30 | 727 CTN |
| 2018061639686 | Anvers,Belgium -> New York, New York | MEDECINES +20 CEL HS CODE 3006.30 | 727 CTN |
| 2018050870002 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | MEDICAMENT +18CEL SCAC CODE DMAL LEH246827 | 77 PLT |
| 2018050870002 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | MEDICAMENT +18CEL LEH246827 SCAC CODE DMAL | 77 PLT |
| 2018050870002 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | MEDICAMENT +18CEL SCAC CODE: DMAL LEH246827 | 77 PLT |
| 2018050870002 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | MEDICAMENT +18CEL SCAC CODE DMAL LEH246817 | 77 PLT |
| 2018033114432 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | MEDICAMENTS DOCTAREM + 18 CEL HS CODE : 3006.30 SCAC CODE DMAL LEH245940 | 40 PLT |
| 2018033114432 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | MEDICAMENTS DOCTAREM + 18 CEL HS CODE : 3006.30 SCAC CODE DMAL LEH245940 | 40 PLT |
| 2018032123716 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | MEDICAMENTS + 18 CEL | 19 PLT |
| 2018031932049 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | MEDICAMENTS + 18 CEL | 19 PLT |
| 2018030335386 | Le Havre,France -> New York/Newark Area, Newark, New Jersey | PHARMACEUTICAL PRODUCT + 18 CEL HS CODE 3006.30 | 19 PLT |
| 2018021641274 | Anvers,Belgium -> New York/Newark Area, Newark, New Jersey | MEDICAMENT DOTAREM | 55 PLT |
| 2018021641274 | Anvers,Belgium -> New York/Newark Area, Newark, New Jersey | MEDICAMENT DOTAREM | 55 PLT |
| 2018021641274 | Anvers,Belgium -> New York/Newark Area, Newark, New Jersey | MEDICAMENT DOTAREM | 55 PLT |