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
07540196000017HYDRIM L110W G4 Instrument WasherL110W-D01-G4L110W-D01-G42016-08-02
07540196000024HYDRIM L110W G4 Instrument WasherL110W-D01-G4-RL110W-D01-G4-R2016-08-02
07540196000031HYDRIM L110W Instrument WasherL110W-D01-RL110W-D01-R2016-08-02
07540196000048HYDRIM C51W Instrument WasherC51W-D01-RC51W-D01-R2016-08-02
07540196000642HYDRIM C61W G4 Instrument WasherC61W-D01C61W-D012016-08-02
07540196000666HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01C61WD-D012016-08-02
07540196000673HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LCSC61WD-D01-LCS2016-08-02
07540196000680HYDRIM L110W G4 Instrument WasherL110W-D01SH-G4L110W-D01SH-G42018-09-07
07540196000994HYDRIM L110W G4 Instrument WasherL110W-D01-G4-LL110W-D01-G4-L2018-01-17
07540196001007HYDRIM L110W Instrument WasherL110W-D01-LL110W-D01-L2018-01-17
07540196001236HYDRIM C51W Instrument WasherC51W-D01-LC51W-D01-L2018-01-17
07540196001250HYDRIM C61W G4 Instrument WasherC61W-D01-LC61W-D01-L2018-01-17
07540196001267HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LC61WD-D01-L2018-01-17
07540196001274HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-RC61WD-D01-R2018-01-17
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

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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
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10705037018154CIDEZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
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00724995229559PRE-KLENZSTERIS CORPORATIONFLG2025-12-16
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D661UC50DB230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230UK1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
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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