FDA.reportPublic FDA data

STERILUCENT, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30110265643011026564STERILUCENT, INC.1N2020-04-251400 Marshall Street NE Minneapolis MN US 55413

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850012210009Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V - HC 80TT-120-0011-877-721-8405CustomerService@Sterilucent.com
00850012210023Sterilucent™ Sterilant Disc - SL0011-877-721-8405CustomerService@Sterilucent.com
00850012210030Sterilucent™ Sterilant Disc - SL0011-877-721-8405CustomerService@Sterilucent.com
00850012210054Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle - SL2901-877-721-8405CustomerService@Sterilucent.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1741661100520526K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge DeviceFRC2019-10-22
1741661126341299K190005Sterilucent HC 80TT Hydrogen Peroxide SterilizerMLR2019-09-13
1741661413237916K141312STERILUCENT PROCESS CHALLENGE DEVICEFRC2014-10-31
1741661297320426K140464STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZERMLR2014-10-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRC22019-10-22
MLR22019-09-13

PMN#

GUDID#