Sterilucent Inc

FDA Filings

This page includes the latest FDA filings for Sterilucent 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: 3011026564
• FEI Number: 3011026564
• Name: STERILUCENT, INC.
• Owner & Operator: Sterilucent, Inc.
• Contact Address: 1400 Marshall Street NE ; Minneapolis MN 55413 US
• Official Correspondent:
  • Roger Martin
  • 1-612-7673258-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1400 Marshall Street NE ; Minneapolis, MN 55413 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 00850012210078 STERILUCENT, INC.	Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle SL291	2020-05-07
GUDID 00850012210054 STERILUCENT, INC.	Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle SL290	2020-05-07
GUDID 00850012210030 STERILUCENT, INC.	Sterilucent™ Sterilant Disc SL001, SL279	2020-05-07
GUDID 00850012210009 STERILUCENT, INC.	Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V HC 80TT-120-001	2020-05-06
PMN K192001 | FRC STERILUCENT, INC.	Sterilucent? Lumen Cycle Process Challenge Device	2020-04-10
PMN K192001 | FRC STERILUCENT, INC.	Sterilucent? Flexible Cycle Process Challenge Device	2020-04-10
PMN K190005 | MLR STERILUCENT, INC.	Sterilucent? HC 80TT Hydrogen Peroxide Sterilizer	2020-04-10
PMN K141312 | FRC STERILUCENT, INC.	Sterilucent? Process Challenge Device Non-Lumen (PCD-NL)	2020-02-27
PMN K141312 | FRC STERILUCENT, INC.	Sterilucent? Process Challenge Device Lumen (PCD-L)	2020-02-27
PMN K140464 | MLR STERILUCENT, INC.	Sterilucent? Sterilant Disc	2020-02-27
PMN K140464 | MLR STERILUCENT, INC.	Sterilucent? PSD-85 Hydrogen Peroxide Sterilizer	2020-02-27
PMN K192001 Sterilucent, Inc.	Sterilucent Self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device	2019-10-22
PMN K191999 Sterilucent, Inc.	Sterilucent VH2O2 Chemical Indicators	2019-10-21
PMN K190005 Sterilucent, Inc.	Sterilucent HC 80TT Hydrogen Peroxide Sterilizer	2019-09-13
PMN K142109 STERILUCENT, INC	STERILUCENT STERILIZATION CONTAINER SYSTEM	2015-01-20
PMN K141238 STERILUCENT, INC	STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR	2014-11-03
PMN K141312 STERILUCENT, INC	STERILUCENT PROCESS CHALLENGE DEVICE	2014-10-31
PMN K140464 STERILUCENT, INC	STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER	2014-10-31

Related Finance Registrations

NCAGE Code	3DS95	STERILUCENT, INC.
CAGE Code	3DS95	STERILUCENT, INC.
S.A.M. Registration	3DS95 [5634969]	STERILUCENT, INC.
DUNS	005634969	STERILUCENT, INC.
SEC	0001514013	Sterilucent, Inc. of MINNESOTA