FDA.reportPublic FDA data

StatClean Ultrasonic Cleaner

Primary DI
07540196002370
Brand
StatClean Ultrasonic Cleaner
Company
Scican Ltd
Model
SC-P4862
Catalog number
SC-P4862
Device description
Ultrasonic Cleaner
Published
2020-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
07540196002370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540196002370075401960023707540196002370

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic water bathA mains electricity (AC-powered) device used for the cleansing of instruments/utensils using ultrasonic waves transmitted from its integral transducers through the water contained in the bath. A dedicated cleansing agent may be added to the water to enhance the cleansing effect.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18006677733tboyce@scican.com

Regulatory Flags#

DUNS number
204137145
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540196001786STATCLAVE G4 Chamber AutoclaveG4-621103G4-6211032019-08-13
07540196003803STATCLAVE G4 Chamber AutoclaveG4-621103-RG4-621103-R2022-04-07
07540196003810STATCLAVE G4 Chamber AutoclaveG4-621103-LG4-621103-L2022-04-07
07540196001793STATCLAVE G4 Chamber AutoclaveG4-622303G4-6223032021-08-18
07540196003179STATIM 5000 G4 Cassette AutoclaveG4-211103G4-2111032023-06-26
07540196003186STATIM 5000 G4 Cassette AutoclaveG4-211103-LG4-211103-L2023-06-26
07540196003193STATIM 5000 G4 Cassette AutoclaveG4-211103-RG4-211103-R2023-06-26
07540196002455BRAVO G4 Chamber Autoclave7A6200307A6200302022-11-18
07540196002462BRAVO G4 Chamber Autoclave7A6210307A6210302022-11-18
07540196002479BRAVO G4 Chamber Autoclave7A6200107A6200102022-11-18
07540196002486BRAVO G4 Chamber Autoclave7A6210107A6210102022-11-18
07540196000420STATIM 5000 G4 Cassette AutoclaveG4-201103G4-2011032016-08-02
07540196000437STATIM 5000 G4 Cassette AutoclaveG4-201103-LG4-201103-L2016-08-02
07540196000444STATIM 5000 G4 Cassette AutoclaveG4-201103-RG4-201103-R2016-08-02
07540196000451STATIM 2000 G4 Cassette AutoclaveG4-121101G4-1211012016-08-02
07540196000475STATIM 2000 G4 Cassette AutoclaveG4-121101-RG4-121101-R2016-08-02
07540196000642HYDRIM C61W G4 Instrument WasherC61W-D01C61W-D012016-08-02
07540196000666HYDRIM C61WD G4 Instrument Washer-Disinfector C61WD-D01C61WD-D012016-08-02
07540196000673HYDRIM C61WD G4 Instrument Washer-Disinfector C61WD-D01-LCS C61WD-D01-LCS 2016-08-02
07540196001250HYDRIM C61W G4 Instrument WasherC61W-D01-LC61W-D01-L2018-01-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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