FDA.reportPublic FDA data

Steelco

Primary DI
08051520011993
Brand
Steelco
Company
STEELCO SPA
Model
US 100 XL
Catalog number
US 100 XL
Device description
The device is the washing (with or without ultrasounds) of surgical instruments, equipment and objects normally used in hospital wards and medical studios.
Published
2023-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FLGCleaner, Ultrasonic, Medical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051520011993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051520011993080515200119938051520011993

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic-cleaning water bathAn electrically-powered device intended to be used to clean instruments/utensils with ultrasonic waves transmitted from its integral transducers through water contained in a bath. A dedicated cleaning agent may be added to the water to enhance the cleaning effect.

Regulatory Flags#

DUNS number
428717469
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051520024108SteelcoTW 3000/2TW 3000/22026-05-26
08051520022876SteelcoDS 1000 2SDS 1000 2S2026-04-17
08051520022852SteelcoDS 1000 2SDS 1000 2S2026-03-27
08051520022869SteelcoDS 1000 2SDS 1000 2S2026-02-04
08051520021176SteelcoDS 1000 2SDS 1000 2S2025-10-28
08051520021770SteelcoLC 80/3LC 80/32025-09-24
08051520021763SteelcoLC 80/2LC 80/22025-09-16
08051520011337SteelcoED 100/1ED 100/1 2025-07-24
08051520021473SteelcoTW 3000/2TW 3000/22025-07-24
08051520021480SteelcoLC 80/2LC 80/22025-07-24
08051520020957SteelcoDS 1000 2SDS 1000 2S2025-06-30
08051520021350SteelcoDS 1000 1SDS 1000 1S2025-06-18
08051520021145SteelcoID 300/1ID 300/12025-05-22
08051520021190SteelcoDS 1000 N1SDS 1000 N1S2025-05-22
08051520021169SteelcoDS 1000 2SDS 1000 2S2025-05-08
08051520020940SteelcoDS 1000 2SDS 1000 2S2025-05-05
08051520021022SteelcoAD 400/2AD 400/22025-04-22
08051520020797SteelcoDS 1000 NDS 1000 N2025-04-10
08051520020667SteelcoAD 400/2AD 400/22025-03-24
08051520020636SteelcoBP 100 HSEBP 100 HSE2025-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995218864PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
50724995218848PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
50724995218855PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
00724995231057ProlysticaSTERIS CORPORATIONFLG2026-01-14
00724995231064ProlysticaSTERIS CORPORATIONFLG2026-01-14
00724995231071ProlysticaSTERIS CORPORATIONFLG2026-01-14
10705037018062ENZOL™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018130CIDEZYME™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018154CIDEZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018161CIDEZYME™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
00724995229559PRE-KLENZSTERIS CORPORATIONFLG2025-12-16
D661UC300230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230UK1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
H816GEL121Spec Clean Pre Treatment GelMicroCare, LLCFLG2025-10-23
H816OP1281OptizymeMicroCare, LLCFLG2025-10-23
H816EZ128Spec Clean Single Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816EZTAB641Spec Clean Enzymatic TabletsMicroCare, LLCFLG2025-10-22
H816PCNF128Spec Clean Instrument Detergent AlkalineMicroCare, LLCFLG2025-10-22
H816PLC128Spec Clean Concentrated Instrument LubricantMicroCare, LLCFLG2025-10-22
H816PLR32Spec Clean Instrument LubricantMicroCare, LLCFLG2025-10-22
H816PREZ128Spec Clean Dual Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZ275Spec Clean Dual Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZAW050Spec Clean Quad Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZAW128Spec Clean Quad Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZF128Spec Clean Pre Treatment Foam SprayMicroCare, LLCFLG2025-10-22
H816PREZF240Spec Clean Pre Treatment Foam SprayMicroCare, LLCFLG2025-10-22
H816PRR050Spec Clean Rinse AgentMicroCare, LLCFLG2025-10-22
H816PRR128Spec Clean Rinse AgentMicroCare, LLCFLG2025-10-22
H816PVAC128Spec Clean Evacuation System CleanerMicroCare, LLCFLG2025-10-22