FDA.reportPublic FDA data

Guerbet

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30071993093007199309Guerbet1N2020-04-2516 rue Gay Lussac Gonesse Val-dOise FR 95500

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2354971170339015K151960Sterile High-pressure Angiographic Syringes for Single-useDXT2016-01-07
2354971084274648

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXT12016-01-07

NDC#

DOTAREM

Guerbet LLC

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DOTAREM

Guerbet LLC

gadoterate meglumine

DOTAREM

Guerbet LLC

gadoterate meglumine

DOTAREM

Guerbet LLC

gadoterate meglumine

DOTAREM

Guerbet LLC

gadoterate meglumine

Applications#