FDA.reportPublic FDA data

Sterile Shield

Primary DI
07350101640029
Brand
Sterile Shield
Company
Toul Meditech AB
Model
LAF-02
Device description
The Sterile shield LAF 02 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 has laminar character which forms the air to a parallel stream of turbulence free ultra clean air. The sterile shield LAF 02 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 is included in both the Operator’s manual and short form instructions. In addition, the label itself has an illustrative short form instruction.
Published
2019-02-13
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
07350101640036PackageGS12In Commercial Distribution
07350101640029PrimaryGS10
07350101640012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350101640036073501016400367350101640036
07350101640029073501016400297350101640029
07350101640012073501016400127350101640012

GMDN Terms#

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

Sterilization Methods#

Method table
Method

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
07350101640067Sterile ShieldLAF-02-D2019-12-20
07350101640098SurgiCube drapeSCDR1802020-12-10
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
07350101640067Sterile ShieldToul Meditech ABORC2019-12-20
07350101640050Sterile ShieldToul Meditech ABORC2019-12-20
07350101640043SteriStayToul Meditech ABORC2019-09-05
07350101640005OperioToul Meditech ABORC2019-04-08
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