FDA.reportPublic FDA data

Evolyse

Primary DI
G0602010210
Brand
Evolyse
Company
Amil Care Corp.
Model
basic 1L
Catalog number
2010.21
Device description
Aerial disinfectant for non-invasive medical devices and surfaces
Published
2023-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRJDisinfectant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G0602010210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection agentA non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082275360
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G0602010230Evolysestrong 1L2010.232023-12-04
G0602010410Sterilbiosbasic 1L2010.412023-12-04
G0602010430Sterilbiosstrong 1L2010.432023-12-04
G0602020210Evolysebasic 2L2020.212023-12-04
G0602020230Evolysestrong 2L2020.232023-12-04
G0602020410Sterilbiosbasic 2L2020.412023-12-04
G0602020430Sterilbiosstrong 2L2020.432023-12-04
G0602023T0Teknobios1L-2L-5L (hub)2023.t2023-12-04
G0602024M0Maxibioshub2024.m2023-12-04
G0602026K0My Linkh-s-w2026.k2023-12-04
G0602030210Evolysebasic 5L2030.212023-12-04
G0602030230Evolysestrong 5L2030.232023-12-04
G0602030410Sterilbiosbasic 5L2030.412023-12-04
G0602030430Sterilbiosstrong 5L2030.432023-12-04
G0602032B0Medibios basic2032.b2023-12-04
G0602034S0Medibios plus2034.s2023-12-04

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Primary DI, Brand, Company table
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10197344169085MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
20197344169082MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-12-09
00850080488072flysoundShenzhen Flysounds Medical Technology Co.,Ltd.LRJ2025-11-14
H816PSC050Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantMicroCare, LLCLRJ2025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantMicroCare, LLCLRJ2025-10-23
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10615375013479CaviCide HPMETREX RESEARCH, LLCLRJ2025-08-04
00815027010303DALTON WET WIPEDALTON MEDICAL CORPORATIONLRJ2025-05-15
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10197344017683MEDLINEMEDLINE INDUSTRIES, INC.LRJ2025-02-28
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