FDA.reportPublic FDA data

Ultra Clean Systems

Primary DI
07340153711815
Brand
Ultra Clean Systems
Company
Getinge Disinfection AB
Model
Getinge 1150
Published
2026-02-25
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
07340153711815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340153711815073401537118157340153711815

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
354023236
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
07340153710344Getinge Aquadis 5656A2022-12-23
07340153710351Getinge Aquadis 5656M2022-12-23
07340153700147GETINGE 91-SERIES91229122-0022016-09-22
07340153700161GETINGE 91-SERIES91289128-0022016-09-22
07340153700246GETINGE 86-SERIESS-8666S-866620012016-09-22
07340153700253GETINGE 86-SERIESS-8666S-866620032016-09-22
07340153710023GETINGE 9100-SERIES9120E9120E-0012017-11-16
07340153710030GETINGE 9100-SERIES9122EW9122EW-0012017-11-16
07340153710047GETINGE 9100-SERIES9125E9125E-0012017-11-16
07340153710054GETINGE 9100-SERIES9127E9127E-0012017-11-16
07340153710061GETINGE 9100-SERIES9128E9128E-0012017-07-10
07340153710078GETINGE 9100-SERIES9128EW9128EW-0012017-11-16
07340153710160GETINGE 46-SERIES46-446-4-402K9682017-03-06
07340153710191GETINGE 1600-SERIESFD1600FD1600-0012017-04-12
07340153710207GETINGE 1800-SERIESFD1800FD1800K902IP242017-04-12
07340153710214GETINGE 1800-SERIESFD1810FD1810-0012017-04-12
07340153710221GETINGE 1800-SERIESFD1810FD1810-001K9062017-04-12
07340153710238GETINGE 1800-SERIESFD1810FD1810-001K9212017-04-12
07340153710245GETINGE 600-SERIESS-607S-6070104SE022017-04-12
07340153710269Getinge 86-SeriesS-8668TS-8668T10012018-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456222515JMUJMU DENTAL, INCFLG2026-07-20
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