Steritec Products Mfg Co Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 2028456
• FEI Number: 1000125215
• Name: SteriTec Products Mfg., Co., Inc.
• Owner & Operator: Getinge Infection Control AB
• Contact Address: Ekebergsvagen 26 ; Getinge SE-NOTA 305 75 SE
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 74 INVERNESS DR E ; Englewood, CO 80112 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K200252 SteriTec Products MFG Co Inc	Getinge Assured MI Steam Migrating Integrator	2020-05-21
PMN K990246 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERI-PAK LF BOWIE-DICK TEST PACK	2015-12-02
PMN K982547 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR	2015-12-02
PMN K982188 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERI-PAK BOWIE DICK TEST PACK	2015-12-02
PMN K981497 | FRC SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS	2015-12-02
PMN K972300 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	CROSS-CHECKS P	2015-12-02
PMN K965212 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM	2015-12-02
PMN K961721 | FRC SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC DISPOSABLE BIOLOGICAL TEST PACK	2015-12-02
PMN K960441 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	SteriTec Steam Integrator X2	2015-12-02
PMN K960441 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC INTEGRAPH	2015-12-02
PMN K955426 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC CROSS-CHECKS	2015-12-02
PMN K953122 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC DRY HEAT INDICATOR LABEL	2015-12-02
PMN K952244 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	CROSS-CHECKS EO GAS STERILIZATION MONITOR	2015-12-02
PMN K951113 | LRT SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	CROSS-CHECKS	2015-12-02
PMN K133549 | FRC SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	SteriTec Biological Test Pack with Instant Readout Integrator	2015-12-02
PMN K133322 | FRC SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	SteriTec Smart Read Biological Test Pack with Instant Readout Integrator	2015-12-02
PMN K132372 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	SteriTec Green Card Pack Bowie-Dick Test	2015-12-02
PMN K122555 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	SteriTec Green Tape	2015-12-02
PMN K111150 | FRC SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR	2015-12-02
PMN K103000 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	SteriTec Smart Read Biological Test Pack with Instant Readout Integrator	2015-12-02
PMN K083650 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	SteriTec Emu-Graph 4 Emulator	2015-12-02
PMN K080136 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK	2015-12-02
PMN K052516 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC CONTAINER CARD	2015-12-02
PMN K040901 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC EMU-GRAPH	2015-12-02
PMN K024293 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	Green Card Bowie-Dick Test Card	2015-12-02
PMN K012732 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	INTEGRAPH FLASH	2015-12-02
PMN K010534 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	CROSS-CHECKS DUAL,	2015-12-02
PMN K003533 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	CROSS-CHECKS LF,	2015-12-02
PMN K003002 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERILIZATION PROCESS INDICATOR TAPE	2015-12-02
PMN K002861 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	EO GAS STERILIZATION PROCESS INDICATOR TAPES	2015-12-02
PMN K001649 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STERITEC BLUE AUTOCLAVE TAPES	2015-12-02
PMN K001444 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	Steam Biological Test Pack w/ Integ	2015-12-02
PMN K000502 | JOJ SteriTec Products Mfg., Co., Inc. [Getinge Infection Control AB]	STEAM/EO RECORD CARD	2015-12-02
PMN K133549 STERITEC PRODUCTS MFG., CO., INC.	STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR	2014-08-27
PMN K133322 STERITEC PRODUCTS MFG., CO., INC.	STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR	2014-08-25
PMN K132372 STERITEC PRODUCTS MFG. CO., INC.	STERITEC GREEN CARD PACK BOWIE-DICK TEST	2013-11-26
PMN K122945 STERITEC PRODUCTS MFG. CO., INC.	STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126	2013-04-30
PMN K122555 STERITEC PRODUCTS MFG. CO., INC.	STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE	2012-12-12
PMN K111150 STERITEC PRODUCTS MFG. CO., INC.	STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR	2011-07-08
PMN K103000 STERITEC PRODUCTS MFG. CO., INC.	SMART READ BIOLOGICAL TEST PACK	2011-02-11
PMN K000502 STERITEC PRODUCTS MFG. CO., INC.	STEAM/EO RECORD CARD, MODEL CI 121	2000-03-14
PMN K990246 STERITEC PRODUCTS MFG. CO., INC.	STERI-PAK LF BOWIE-DICK TEST PACK	1999-06-10
PMN K982188 STERITEC PRODUCTS MFG. CO., INC.	STERI-PAK BOWIE DICK TEST PACK	1998-11-20
PMN K981497 STERITEC PRODUCTS MFG. CO., INC.	STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS	1998-10-29
PMN K982547 STERITEC PRODUCTS MFG. CO., INC.	STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR	1998-10-08
PMN K965212 STERITEC PRODUCTS MFG. CO., INC.	STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM	1998-04-23
PMN K972300 STERITEC PRODUCTS MFG. CO., INC.	CROSS-CHECKS P	1998-03-25
PMN K960441 STERITEC PRODUCTS MFG. CO., INC.	STERITEC INTEGRAPH MODEL CI-101	1997-05-08
PMN K953122 STERITEC PRODUCTS MFG. CO., INC.	STERITEC DRY HEAT INDICATOR LABEL	1997-04-02
PMN K961721 STERITEC PRODUCTS MFG. CO., INC.	STERITEC DISPOSABLE BIOLOGICAL TEST PACK	1996-08-23
PMN K951113 STERITEC PRODUCTS MFG. CO., INC.	CROSS-CHECKS	1996-08-19
PMN K952244 STERITEC PRODUCTS MFG. CO., INC.	CROSS-CHECKS EO GAS STERILIZATION MONITOR	1996-08-05
PMN K955426 STERITEC PRODUCTS MFG. CO., INC.	STERITEC CROSS-CHECKS	1996-03-12