Product code OWP

Device name: Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
Medical specialty: General Hospital
Device class: 2
Regulation number: 880.2805
Review panel: HO
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K181442	VERIFY Assert Self-Contained Biological Indicator	STERIS Corporation	2018-06-13
K162945	VERIFY ASSERT STEAM Process Challenge Device	STERIS Corporation	2017-04-28
K162701	VERIFY Assert Self-Contained Biological Indicator	STERIS Corporation	2017-03-24
K163587	VERIFY Incubator for Assert Self Contained Biological Indicators	STERIS Corporation	2017-03-24
DEN110006	VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR	STERIS Corporation	2013-07-12

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00724995201838	VERIFY	STERIS CORPORATION	2022-04-25
00724995002541	VERIFY	STERIS CORPORATION	2019-04-01
10724995153028	VERIFY Assert	STERIS CORPORATION	2017-07-27
10724995153035	VERIFY Assert	STERIS CORPORATION	2017-07-27
00724995153052	VERIFY	STERIS CORPORATION	2017-07-27
10724995153011	VERIFY Assert	STERIS CORPORATION	2017-07-01

Related 510(k) Records#