FDA.reportPublic FDA data

Lexa MINI RIS-305

Primary DI
E30819935111
Brand
Lexa MINI RIS-305
Company
W & H STERILIZATION SRL
Model
Lexa MINI RIS-305
Catalog number
19935111
Device description
TABLE-TOP STERILIZER LEXA MINI RIS-305
Published
2023-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E30819935111PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
E308199451100Lexa MINI RIS-305Lexa MINI RIS-305199451102023-07-31
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

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