FDA.reportPublic FDA data

Lexa MINI RIS-305

Primary DI
E308199451100
Brand
Lexa MINI RIS-305
Company
W & H STERILIZATION SRL
Model
Lexa MINI RIS-305
Catalog number
19945110
Device description
TABLE-TOP STEAM STERILIZER LEXA MINI RIS-305
Published
2023-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223858000
K233504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223858000Lexa MINI (RIS-303, RIS-305)W&H Sterilization S.R.L.2023-05-05FLE
K233504000Lexa MINI (RIS-303, RIS-305)W&H Sterilization S.R.L.2024-02-08FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E308199451100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429111904
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E308210050010Talos+ RIW-100TTTalos+ RIW-100TT210050012025-12-23
E308210060010Talos+ RIW-100UCTalos+ RIW-100UC210060012025-12-23
E308199331000Lexa PLUS RIS-311Lexa PLUS RIS-311199331002022-09-05
E308199331010Lexa PLUS RIS-311Lexa PLUS RIS-311199331012022-09-05
E308199351110Lexa MINI RIS-305Lexa MINI RIS-305199351112023-07-31
E308199352110Lexa MINI RIS-305Lexa MINI RIS-305199352112023-07-31
E308199352120Lexa MINI RIS-305Lexa MINI RIS-305199352122024-03-11
E308199441100Lexa MINI RIS-303Lexa MINI RIS-303199441102023-07-31
E308199442100Lexa MINI RIS-303Lexa MINI RIS-303199442102023-07-31
E308199452100Lexa MINI RIS-305Lexa MINI RIS-305199452102023-07-31
E308199431310MN-111MN-111199431312021-10-14
E308199434310MN-111MN-111199434312021-10-14
E308199431000MN-111MN-111199431002018-09-25
E308199431010MN-111MN-111199431012019-01-08
E308199431100MN-111MN-111199431102019-01-08
E308199431110MN-111MN-111199431112019-01-08
E308199431200SNA30MN-111199431202018-12-21
E308199434000MN-111MN-111199434002018-09-25
E308199434010MN-111MN-111199434012019-01-08
E308199434100MN-111MN-111199434102019-01-08

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