FDA.reportPublic FDA data

ADVANCED STERILIZATION PRODUCTS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20847253003662624ADVANCED STERILIZATION PRODUCTS1Y2026-01-0133 TECHNOLOGY DRIVE Irvine CA US 92618

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
10705037000562EVOTECH™ - Channel Connector Tube, White+1(888)783-7723ASP-Complaints@asp.com
10705037014132STERRAD NX™ - STERRAD NX™ Sterilizer+1(888)783-7723ASP-Complaints@asp.com
10705037016198STERRAD™ - STERRAD™ Chemical Indicator Strip+1(888)783-7723ASP-Complaints@asp.com
10705037016495STERRAD™ - STERRAD™ 100NX International Validation Kit+1(888)783-7723ASP-Complaints@asp.com
10705037016952STERRAD™ - Incubator 120V 58 C+1(888)783-7723ASP-Complaints@asp.com
10705037045006EVOTECH™ - Channel Connector Tube, Brown+1(888)783-7723ASP-Complaints@asp.com
10705037048908STERRAD VELOCITY™ - STERRAD VELOCITY™ Biological Indicator / Process Challenge Device, 60 Count+1(888)783-7723ASP-Complaints@asp.com
10705037049400STERRAD VELOCITY™ - STERRAD VELOCITY™ Biological Indicator / Process Challenge Device, 30 Count+1(888)783-7723ASP-Complaints@asp.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
817661834868600K991999STERRAD 100S STERILIZERMLR2000-06-15
817662033956448K981054BROWNE GA INDICATOR FOR CIDEX PRODUCTSJOJ1998-12-07
817661864243153K951295STERRAD STERILIZATION POUCHKCT1995-05-19
817661844749839K923744CIDEX PLUS 28 DAY SOLUTIONLRJ1994-03-29
817661270744809K921910STERRAD CHEMICAL INDICATORJOJ1993-10-04
817661705472621K251354UV Smart D60SCS2026-01-29
817661266004064K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)JOJ2024-07-05
817661107133020K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)MLR2024-07-05
817661446259088K220404STERRAD NX with ALLClear TechnologyMLR2022-05-16
817661918324441K212174STERRAD 100NX Sterilizer with ALLClear TechnologyMLR2021-10-09
817661227472029K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderFRC2020-01-23
817661919881886K182404STERRAD VELOCITY Biological IndicatorFRC2018-12-27
817661943372035K181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorFEB2019-04-23
817661937410244K170039STERRAD VELOCITY Biological Indictator and ReaderFRC2017-06-20
817661449483644K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical IndicatorKCT2017-07-31
817661820249017K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyMLR2016-09-26
817661139076008K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyMLR2016-09-27
817662003846775K152189EVOTECH ECRFEB2016-07-20
817661603212605K151971STERRAD CYCLESURE 24 Biological IndicatorFRC2015-10-29
817662057128623K151725STERRAD NX Sterilizer, STERRAD 100NX SterilizerMLR2016-01-13
817661189690154K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerMLR2015-04-03
817661683506461K141693Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorFRG2014-12-19
817661357340318K140977EVOTECH ECRFEB2014-12-22
817661455523937K130263STERRAD 50/100S/200 TEST PACKFRC2014-03-28
817661237102774K123017STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324FRC2012-12-26
817661824030111K122044STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATORFRC2012-10-04
817661829794783K112087TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLSKCT2012-10-15
817661331310068K111519STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202JOJ2012-10-03
817661207122316K111518STERRAD CHEMIAL INDICATOR STRIP MODEL 14100JOJ2012-10-03
817661994450901K111391STERRAD (R) 100NX DUO CYCLE TEST PACKFRC2012-09-26
817661309170011K111377STERRAD(R) 100NX STERILIZER DUO CYCLEMLR2012-09-13
817661330921624K111375STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATORFRC2012-09-14
817662046906464K103222STERRAD CYCLESURE BIOLOGICAL INDICATORFRC2011-02-25
817661134325512K103219STERRAD SEALSURE CHEMICAL INDICATOR TAPEJOJ2011-04-01
817661703193731K103218STERRAD CHEMICAL INDICATOR STRIPJOJ2011-04-01
817661867097522K103210TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORSFRG2011-06-06
817661481383697K092755STERRAAD 100NX EXPRESS CYCLE TEST PACKFRC2011-02-25
817661212537115K092622STERRAD 100NX STERILIZER EXPRESS CYCLEMLR2011-03-04
817661142982758K082392EVOTECH ENDOSCOPE CLEANER AND REPROCESSORFEB2008-11-13
817661508546641K081427BROWNE OPA TEST STRIPJOJ2008-06-11
817661393081618K071537STERRAD 100NX TEST PACKFRC2007-12-18
817661331967271K071385STERRAD 100NX STERILIZERMLR2007-11-29
817661545218013K060618CIDEX ACTIVATED DIALDEHYDE SOLUTIONMED2006-04-12
817661815873321K051643STERRAD STERILIZER CYCLESURE TEST PACKFRC2005-08-19
817661677398784K042450STERRAD NX CHALLENGE PACKFRC2005-05-12
817661770522077K042116STERRAD NX STERILIZERMLR2005-04-22
817661109241865K040742MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPEJOJ2004-04-02
817661071047082K0300040.55% ORTH-PHTHALALDEHYDE SOLUTIONMED2003-02-27
817661171513659K023290STERRAD 50 & STERRAD 100S STERILIZERSFLF2003-04-03
817661936500344K013003APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDERFRG2002-08-28
817661528814711
817661774712089
817661306620045
817661387773902
817661401245165
817661822835941
817661917612877
817661971003052

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRC142020-01-23
MLR122024-07-05
JOJ92024-07-05
FEB42019-04-23
KCT32017-07-31
FRG32014-12-19
MED22006-04-12
SCS12026-01-29
FLF12003-04-03
LRJ11994-03-29

PMN#

62 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next