Product code ORC

Device name: Air Filter Portable Apparatus
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation number: 878.5070
Review panel: HO
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Definition: The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K190027	SteriStay	Toul Meditech AB	2019-05-10
K173349	Operio	Toul Meditech AB	2017-12-20
K163455	SurgiCube	Surgicube International B.V.	2017-09-28
K153498	Operio	Toul Meditech AB	2016-07-20
K123006	AIR BARRIER SYSTEM (ABS)	Nimbic Systems, Inc.	2013-12-20
K092801	ABS BLOWER, ABS NOZZLE, MODEL 1001	Nimbic Systems, LLC	2011-05-20

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00842430115738	HANA DISPOSA-PULL P-POST COVER	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2021-05-31
00842430115455	ABS HOOK AND LOOP PAD	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2021-02-19
00842430115448	AIR BARRIER SYSTEM STERILE NOZZLE	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2021-02-19
00842430115462	AIR BARRIER SYSTEM BLOWER	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2021-02-19
00842430115745	ABS HOOK AND LOOP PAD	MIZUHO ORTHOPEDIC SYSTEMS, INC.	2021-02-19
07350101640067	Sterile Shield	Toul Meditech AB	2019-12-20
07350101640050	Sterile Shield	Toul Meditech AB	2019-12-20
07350101640043	SteriStay	Toul Meditech AB	2019-09-05
07350101640005	Operio	Toul Meditech AB	2019-04-08
07350101640029	Sterile Shield	Toul Meditech AB	2019-02-13
00869284000249	ABS Blower Unit	NIMBIC SYSTEMS, INC.	2018-11-15
00869284000201	ABS Nozzle	NIMBIC SYSTEMS, INC.	2016-10-20
00869284000232	ABS Nozzle	NIMBIC SYSTEMS, INC.	2016-10-20
00869284000225	ABS Velcro Pad	NIMBIC SYSTEMS, INC.	2016-10-20

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