FDA.reportPublic FDA data

THE O R COMPANY PTY LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30082541273008254127THE O R COMPANY PTY LTD1N2026-01-014/47 Wangara Road Cheltenham Victoria AU 3192

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1142281558593726K220202Uterine ElevatOR PRO with OccludOR BalloonLKF2022-03-31
1142281807243153K212505DUMI ManipulatORLKF2022-01-10
1142281695803828K181887AMD Anti-Fog SolutionOCT2019-01-22
1142281889214828K150519ManipulatOR PRO, ManipulatORLKF2015-08-19
1142281565936963K142700InsufflatOR NeedleHIF2014-12-19
1142281591951945K142164MANIPULATOR; MANIPULATOR PROLKF2014-12-17
1142281324575887K092980PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5LKF2010-03-11
1142281533049285K051594MCCARTNEY ACCESS TUBEHEW2005-09-02
1142281041240284
1142281325885143
1142281377370879
1142281600803729
1142281626439332
1142281809774104
1142281865519282

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LKF52022-03-31
OCT12019-01-22
HIF12014-12-19
HEW12005-09-02

PMN#

GUDID#

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