Operio

Primary DI
07350101640005
Brand
Operio
Company
Toul Meditech AB
Model
Mobile
Device description
Operio Mobile is a clean air zone unit, with an integrateddetachable instrument tray, to be used in the operatingzone, which produces a directed, non-turbulent ultracleanair flow to the surgical site during ophthalmic,orthopedic and neuro surgery and to the sterileinstruments used during surgery.
Published
2019-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ORCAir Filter Portable Apparatus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORCAir Filter Portable ApparatusGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350101640005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350101640005073501016400057350101640005

GMDN Terms#

Term, Definition table
TermDefinition
Surgical laminar airflow unitAn air-handling unit designed for use in surgical theatres to produce a directed, non-turbulent flow of clean air and thereby provide an area free of contaminants to reduce the possibility of infection to the patient. The air is filtered, usually through a high-efficiency particulate air (HEPA) filter, to remove particulate matter and microorganisms. The unit is fixed, often built-in, typically to the ceiling, and provides a curtain of fast moving air around the perimeter of the area which will form an outer wall and help delineate between the "sterile" and "non-sterile" operation area. An operating light or light system may be mounted to this unit or within the specified area.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
427895198
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350101640067Sterile ShieldLAF-02-D2019-12-20
07350101640098SurgiCube drapeSCDR1802020-12-10
07350101640029Sterile ShieldLAF-022019-02-13
07350101640050Sterile ShieldLAF-02-D2019-12-20
07350101640043SteriStayB22019-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842430115738HANA DISPOSA-PULL P-POST COVERMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-05-31
00842430115455ABS HOOK AND LOOP PADMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
00842430115448AIR BARRIER SYSTEM STERILE NOZZLEMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
00842430115462AIR BARRIER SYSTEM BLOWERMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
00842430115745ABS HOOK AND LOOP PADMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
07350101640067Sterile ShieldToul Meditech ABORC2019-12-20
07350101640050Sterile ShieldToul Meditech ABORC2019-12-20
07350101640043SteriStayToul Meditech ABORC2019-09-05
07350101640029Sterile ShieldToul Meditech ABORC2019-02-13
00869284000249ABS Blower UnitNIMBIC SYSTEMS, INC.ORC2018-11-15
00869284000201ABS NozzleNIMBIC SYSTEMS, INC.ORC2016-10-20
00869284000232ABS NozzleNIMBIC SYSTEMS, INC.ORC2016-10-20
00869284000225ABS Velcro PadNIMBIC SYSTEMS, INC.ORC2016-10-20