De Novo DEN110006

Device: VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
Contact: robert sullivan
De Novo number: DEN110006
Product code: OWP
Regulation: 880.2805
Classification name: biological sterilization process indicator with recombinant-dna plasmid
Decision: granted (DENG)
Decision date: 2013-07-12
Date received: 2011-09-06
Classification advisory: General Hospital
Review advisory: General Hospital
Type: Post-NSE

Current FDA Classification#

Product code: OWP
Device name: Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
Medical specialty: General Hospital
Device class: 2
Regulation: 880.2805
Implant: N
Life sustain/support: N

Primary DI, Device, Company table
Primary DI	Device	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