Advanced Sterilization Products

FDA Filings

This page includes the latest FDA filings for Advanced Sterilization Products. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Advanced Sterilization Products holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3013266776
FEI Number3013266776
NameASP Logistics Center
Owner & OperatorAdvanced Sterilization Products
Contact Address33 Technology Drive --
Irvine CA 92618 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address13135 Napa St
Fontana, CA 92335 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



Registration Number2084725
FEI Number3003662624
NameADVANCED STERILIZATION PRODUCTS
Owner & OperatorAdvanced Sterilization Products
Contact Address33 Technology Drive --
Irvine CA 92618 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address33 TECHNOLOGY DRIVE
Irvine, CA 92618 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
ADVANCED STERILIZATION PRODUCTS
STERRAD VELOCITY READER2020-02-03
ADVANCED STERILIZATION PRODUCTS
STERRAD VELOCITY Biological Indicator / Process Challenge Device 60 Count2020-02-03
ADVANCED STERILIZATION PRODUCTS
STERRAD VELOCITY Biological Indicator / Process Challenge Device 30 Count2020-02-03
ADVANCED STERILIZATION PRODUCTS
AUTOSURE? MRC Reagent2019-05-07
ADVANCED STERILIZATION PRODUCTS
AEROFLEX? Automatic Endoscope Reprocessor with AUTOSURE? MRC Monitor2019-05-07
ADVANCED STERILIZATION PRODUCTS
AERO-OPA? Solution2019-05-07
ADVANCED STERILIZATION PRODUCTS
AUTOSURE? MRC Reagent2019-05-07
ADVANCED STERILIZATION PRODUCTS
AEROFLEX? Automatic Endoscope Reprocessor with AUTOSURE? MRC Monitor2019-05-07
ADVANCED STERILIZATION PRODUCTS
AERO-OPA? Solution2019-05-07
ADVANCED STERILIZATION PRODUCTS
AUTOSURE? MRC Reagent2019-05-07
ADVANCED STERILIZATION PRODUCTS
AEROFLEX? Automatic Endoscope Reprocessor with AUTOSURE? MRC Monitor2019-05-07
ADVANCED STERILIZATION PRODUCTS
AERO-OPA? Solution2019-05-07
ASP Logistics Center [Advanced Sterilization Products]
STERRAD Velocity Biological Indicator2019-01-23
ASP Logistics Center [Advanced Sterilization Products]
STERRAD VELOCITY Validation Kit for STERRAD NX Sterilizer2019-01-23
ASP Logistics Center [Advanced Sterilization Products]
STERRAD VELOCITY Validation Kit for STERRAD 100S Sterilizer2019-01-23
ASP Logistics Center [Advanced Sterilization Products]
STERRAD VELOCITY Validation Kit for STERRAD 100NX Sterilizer2019-01-23
ASP Logistics Center [Advanced Sterilization Products]
STERRAD VELOCITY Validation Kit for EXPRESS2019-01-23
ASP Logistics Center [Advanced Sterilization Products]
STERRAD VELOCITY Validation Kit for EXPRESS-HC2019-01-23
ADVANCED STERILIZATION PRODUCTS
STERRAD Velocity Biological Indicator2019-01-23
ADVANCED STERILIZATION PRODUCTS
STERRAD VELOCITY Validation Kit for STERRAD NX Sterilizer2019-01-23
ADVANCED STERILIZATION PRODUCTS
STERRAD VELOCITY Validation Kit for STERRAD 100S Sterilizer2019-01-23
ADVANCED STERILIZATION PRODUCTS
STERRAD VELOCITY Validation Kit for STERRAD 100NX Sterilizer2019-01-23
ADVANCED STERILIZATION PRODUCTS
STERRAD VELOCITY Validation Kit for EXPRESS2019-01-23
ADVANCED STERILIZATION PRODUCTS
STERRAD VELOCITY Validation Kit for EXPRESS-HC2019-01-23
ASP Logistics Center [Advanced Sterilization Products]
Tyvek Pouch/Roll with STERRAD Chemical Indicator2017-08-21
ADVANCED STERILIZATION PRODUCTS
Tyvek Pouch/Roll with STERRAD Chemical Indicator2017-08-21
ASP Logistics Center [Advanced Sterilization Products]
Tyvek Pouch/Roll with STERRAD Chemical Indicator2017-08-21
ADVANCED STERILIZATION PRODUCTS
Tyvek Pouch/Roll with STERRAD Chemical Indicator2017-08-21
ADVANCED STERILIZATION PRODUCTS
STERRAD CYCLESURE 24 Biological Indicator2017-08-09
ADVANCED STERILIZATION PRODUCTS
Tyvek Self-Seal Pouches With STERRAD Chemical Indicator, Tyvek Rolls With STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches With STERRAD Chemical Indicator2017-07-31
Advanced Sterilization Products
STERRAD NX Sterilizer2017-02-16
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX Sterilization System with ALLClear Technology2016-10-31
ADVANCED STERILIZATION PRODUCTS
STERRAD NX Sterilzation System with ALLClear Technology2016-10-31
ADVANCED STERILIZATION PRODUCTS
EVOTECH ECR2016-10-28
ADVANCED STERILIZATION PRODUCTS
STERRAD® NX Sterilizer With ALLClear™ Technology2016-09-27
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX Sterilizer With ALLClearTM Technology2016-09-26
ASP Logistics Center [Advanced Sterilization Products]
Incubator2016-03-31
ADVANCED STERILIZATION PRODUCTS
Incubator2016-03-31
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX and NX with DTI2016-01-14
ADVANCED STERILIZATION PRODUCTS
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer2016-01-13
ADVANCED STERILIZATION PRODUCTS
STERRAD CYCLESURE 24 Biological Indicator2015-10-29
ASP Logistics Center [Advanced Sterilization Products]
Tyvek Pouch/Roll with STERRAD Chemical Indicator2015-05-26
ADVANCED STERILIZATION PRODUCTS
Tyvek Pouch/Roll with STERRAD Chemical Indicator2015-05-26
ASP Logistics Center [Advanced Sterilization Products]
Tyvek Pouch/Roll with STERRAD Chemical Indicator2015-05-26
ADVANCED STERILIZATION PRODUCTS
Tyvek Pouch/Roll with STERRAD Chemical Indicator2015-05-26
ADVANCED STERILIZATION PRODUCTS
STERRAD 50/100S/200 Test Pack2015-05-26
ADVANCED STERILIZATION PRODUCTS
EVOTECH ECR2015-04-14
ADVANCED STERILIZATION PRODUCTS
STERRAD NX and 100NX with DTI Connectivity2015-04-08
ADVANCED STERILIZATION PRODUCTS
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer2015-04-03
ADVANCED STERILIZATION PRODUCTS
EVOTECH ECR2014-12-22
ADVANCED STERILIZATION PRODUCTS
Tyvek® Pouch/Roll With STERRAD® Chemical Indicator2014-12-19
ADVANCED STERILIZATION PRODUCTS
STERRAD 50/100S/200 TEST PACK2014-03-28
ADVANCED STERILIZATION PRODUCTS
STERRAD CYCLESURE 24 Biological Indicator (DUO Cycle)2013-02-01
ADVANCED STERILIZATION PRODUCTS
Tray2013-02-01
ADVANCED STERILIZATION PRODUCTS
Table2013-02-01
ADVANCED STERILIZATION PRODUCTS
Tray2013-02-01
ADVANCED STERILIZATION PRODUCTS
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 143242012-12-26
ADVANCED STERILIZATION PRODUCTS
STERRAD Cyclesure 24 Biological Indicator2012-11-01
ADVANCED STERILIZATION PRODUCTS
Tyvek Pouch/Roll with STERRAD Chemical Indicator2012-11-01
ADVANCED STERILIZATION PRODUCTS
Tyvek Pouch/Roll with STERRAD Chemical Indicator2012-11-01
ASP Logistics Center [Advanced Sterilization Products]
STERRAD SealSure Chemical Indicator Tape2012-11-01
ADVANCED STERILIZATION PRODUCTS
STERRAD SealSure Chemical Indicator Tape2012-11-01
ASP Logistics Center [Advanced Sterilization Products]
STERRAD Chemical Indicator Strip2012-11-01
ADVANCED STERILIZATION PRODUCTS
STERRAD Chemical Indicator Strip2012-11-01
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX DUO Cycle Test Pack2012-11-01
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX Sterilizer , DUO cycle2012-11-01
ADVANCED STERILIZATION PRODUCTS
STERRAD Cyclesure 24 Biological Indicator2012-11-01
ADVANCED STERILIZATION PRODUCTS
TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS2012-10-15
ADVANCED STERILIZATION PRODUCTS
STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR2012-10-04
ADVANCED STERILIZATION PRODUCTS
STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 142022012-10-03
ADVANCED STERILIZATION PRODUCTS
STERRAD CHEMIAL INDICATOR STRIP MODEL 141002012-10-03
ADVANCED STERILIZATION PRODUCTS
STERRAD (R) 100NX DUO CYCLE TEST PACK2012-09-26
ADVANCED STERILIZATION PRODUCTS
STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR2012-09-14
ADVANCED STERILIZATION PRODUCTS
STERRAD(R) 100NX STERILIZER DUO CYCLE2012-09-13
ADVANCED STERILIZATION PRODUCTS
STERRAD Cyclesure 24 Biological Indicator (EXPRESS Cycle)2011-11-03
ADVANCED STERILIZATION PRODUCTS
STERRAD SealSure Chemical Indicator Tape2011-11-03
ADVANCED STERILIZATION PRODUCTS
STERRAD Chemical Indicator Strip2011-11-03
ADVANCED STERILIZATION PRODUCTS
Tyvek Pouch/Roll with STERRAD Chemical Indicator2011-11-03
ASP Logistics Center [Advanced Sterilization Products]
STERRAD 100 NX EXPRESS Test Pack2011-11-03
ADVANCED STERILIZATION PRODUCTS
STERRAD 100 NX EXPRESS Test Pack2011-11-03
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX Sterilizer, EXPRESS Cycle2011-11-03
ADVANCED STERILIZATION PRODUCTS
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS2011-06-06
ADVANCED STERILIZATION PRODUCTS
STERRAD SEALSURE CHEMICAL INDICATOR TAPE2011-04-01
ADVANCED STERILIZATION PRODUCTS
STERRAD CHEMICAL INDICATOR STRIP2011-04-01
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX STERILIZER EXPRESS CYCLE2011-03-04
ADVANCED STERILIZATION PRODUCTS
STERRAD CYCLESURE BIOLOGICAL INDICATOR2011-02-25
ADVANCED STERILIZATION PRODUCTS
STERRAAD 100NX EXPRESS CYCLE TEST PACK2011-02-25
ADVANCED STERILIZATION PRODUCTS
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR2011-01-28
ADVANCED STERILIZATION PRODUCTS
Adaptor bulbs2009-04-24
ADVANCED STERILIZATION PRODUCTS
EvoTech Integrated Endoscope Disinfection System2008-12-02
ADVANCED STERILIZATION PRODUCTS
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR2008-11-13
ASP Logistics Center [Advanced Sterilization Products]
CycleSure Test Pack2008-05-06
ADVANCED STERILIZATION PRODUCTS
CycleSure Test Pack2008-05-06
ADVANCED STERILIZATION PRODUCTS
50/100S2008-05-06
ADVANCED STERILIZATION PRODUCTS
Pouch2008-01-10
ADVANCED STERILIZATION PRODUCTS
Cidex Plus 28 Day2008-01-10
ADVANCED STERILIZATION PRODUCTS
Chemical Indicator Tape2008-01-10
ASP Logistics Center [Advanced Sterilization Products]
STERRAD 100NX2008-01-10
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX2008-01-10
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX2008-01-10
ADVANCED STERILIZATION PRODUCTS
Cidex Activated Dialdehyde Solution2008-01-10
ASP Logistics Center [Advanced Sterilization Products]
STERRAD NX Test Pack2008-01-10
ADVANCED STERILIZATION PRODUCTS
STERRAD NX Test Pack2008-01-10
ADVANCED STERILIZATION PRODUCTS
CI Tape2008-01-10
ADVANCED STERILIZATION PRODUCTS
Cidex OPA2008-01-10
ASP Logistics Center [Advanced Sterilization Products]
Aptimax Tray2008-01-10
ADVANCED STERILIZATION PRODUCTS
Aptimax Tray2008-01-10
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX TEST PACK2007-12-18
ADVANCED STERILIZATION PRODUCTS
STERRAD 100NX STERILIZER2007-11-29
ADVANCED STERILIZATION PRODUCTS
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR2007-05-24
ADVANCED STERILIZATION PRODUCTS
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM2006-10-26
ADVANCED STERILIZATION PRODUCTS
STERRAD STERILIZER CYCLESURE TEST PACK2005-08-19
ADVANCED STERILIZATION PRODUCTS
STERRAD NX CHALLENGE PACK2005-05-12
ADVANCED STERILIZATION PRODUCTS
STERRAD NX STERILIZER2005-04-22
ADVANCED STERILIZATION PRODUCTS
CIDEX OPA CONCENTRATE2005-04-04
ADVANCED STERILIZATION PRODUCTS
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM2005-03-15
ADVANCED STERILIZATION PRODUCTS
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE2004-04-02
ADVANCED STERILIZATION PRODUCTS
STERRAD 200 STERILIZER2003-08-18
ADVANCED STERILIZATION PRODUCTS
STERRAD CYCLESURE BIOLOGICAL INDICATOR2003-05-02
ADVANCED STERILIZATION PRODUCTS
STERRAD 50 & STERRAD 100S STERILIZERS2003-04-03
ADVANCED STERILIZATION PRODUCTS
0.55% ORTH-PHTHALALDEHYDE SOLUTION2003-02-27
ADVANCED STERILIZATION PRODUCTS
STERRAD SEALSURE CHEMICAL INDICATOR TAPE2002-10-08
ADVANCED STERILIZATION PRODUCTS
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER2002-08-28
ADVANCED STERILIZATION PRODUCTS
STERRAD CYCLESURE BIOLOGICAL INDICATOR2002-02-13
ADVANCED STERILIZATION PRODUCTS
CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)2000-08-29
ADVANCED STERILIZATION PRODUCTS
STERRAD 100S STERILIZER2000-06-15
ADVANCED STERILIZATION PRODUCTS
STERRAD BI TEST PACK2000-06-01
ADVANCED STERILIZATION PRODUCTS
CIDEX OPA SOLUTION2000-05-17
ADVANCED STERILIZATION PRODUCTS
CIDEX OPA SOLUTION1999-10-08
ADVANCED STERILIZATION PRODUCTS
STERRAD 100S1999-07-08
ADVANCED STERILIZATION PRODUCTS
STERRAD NX1999-07-08
ADVANCED STERILIZATION PRODUCTS
STERRAD1999-07-08
ADVANCED STERILIZATION PRODUCTS
MODIFICATION OF: STERRAD BI TEST PACK1999-06-15
ADVANCED STERILIZATION PRODUCTS
STERRAD 50 STERILIZER1999-01-11
ADVANCED STERILIZATION PRODUCTS
STERRADD STERILIZATION SYSTEM1997-06-06
ADVANCED STERILIZATION PRODUCTS
STERRAD STERILIZATION POUCH1995-05-19
ADVANCED STERILIZATION PRODUCTS
STERRAD CHEMICAL INDICATOR TAPE1994-12-29

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