Sterile Shield

Primary DI
07350101640067
Brand
Sterile Shield
Company
Toul Meditech AB
Model
LAF-02-D
Device description
The Sterile shield LAF 02-D is a single-use sterile consumable to be used together with ultra clean air devices from Toul Meditech AB, to function as a sterile protection for preventing airborne contamination in the surgical environment. In addition, the sterile shield LAF 02-D has laminar character which forms the air to a parallel stream of turbulence free ultra clean air. The sterile shield LAF 02-D is attached on the Operio device on the outlet of the HEPA filtered ultra clean air.Instructions on how to use and mount the sterile shield LAF 02-D is included in both the Operator’s manual and short form instructions. In addition, the label itself has an illustrative short form instruction.
Published
2019-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
07350101640050PackageGS12In Commercial Distribution
07350101640067PrimaryGS10
07350101640074Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350101640050073501016400507350101640050
07350101640067073501016400677350101640067
07350101640074073501016400747350101640074

GMDN Terms#

Term, Definition table
TermDefinition
Surgical dressing/drape kit, single-useA collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device.

Regulatory Flags#

DUNS number
427895198
Device count
50
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350101640098SurgiCube drapeSCDR1802020-12-10
07350101640029Sterile ShieldLAF-022019-02-13
07350101640050Sterile ShieldLAF-02-D2019-12-20
07350101640043SteriStayB22019-09-05
07350101640005OperioMobile2019-04-08

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
07350101640050Sterile ShieldToul Meditech ABORC2019-12-20
07350101640043SteriStayToul Meditech ABORC2019-09-05
07350101640005OperioToul Meditech ABORC2019-04-08
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