FDA.reportPublic FDA data

Ultra Clean Systems

Primary DI
07340153715967
Brand
Ultra Clean Systems
Company
Getinge Disinfection AB
Model
Model 1101 RACS tray with S and SI adapters
Published
2026-05-11
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
07340153715967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340153715967073401537159677340153715967

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
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
07340153711792Ultra Clean SystemsGetinge 1100 2026-05-11
07340153711808Ultra Clean SystemsGetinge 11012026-05-11
07340153715813Ultra Clean SystemsModel 1100 - Lumen tray only2026-05-11
07340153715820Ultra Clean SystemsModel 1101 - Lumen Tray only2026-05-11
07340153715868Ultra Clean SystemsXi RACS tray with adapters for Model 11012026-05-11
07340153715875Ultra Clean SystemsSP Tray with adapters - Model 11012026-05-11
07340153715936Ultra Clean SystemsModel 1100 - Lumen Tray with Accessory Kit2026-05-11
07340153715950Ultra Clean SystemsModel 1101 - Lumen Tray with Accessory kit2026-05-11
07340153715998Ultra Clean SystemsXi RACS tray with adapters for Model 11012026-05-11
07340153711815Ultra Clean SystemsGetinge 11502026-02-25
07340153711822Ultra Clean SystemsGetinge 15222026-02-25
07340153711839Ultra Clean SystemsGetinge Triton 36 2026-02-25
07340153711846Ultra Clean SystemsGetinge Triton 72 2026-02-25
07340153715837Ultra Clean SystemsBASKET ASSEMBLY, 1150, 1522 10-01552026-02-25
07340153715844Ultra Clean SystemsBASKET ASSEMBLY, TRITON 36, 72 10-01582026-02-25
07340153715851Ultra Clean SystemsROBOTIC ARM CLEANING BASKET 10-03122026-02-25
07340153715882Ultra Clean SystemsBASKET W/ADAPTER KIT, 36, 72 10-01582026-02-25
07340153715899Ultra Clean SystemsRACS BASKET, S/SI ADAPTERS 10-01582026-02-25
07340153715905Ultra Clean SystemsRACS BASKET, Xi ADAPTERS 10-03242026-02-25
07340153715912Ultra Clean SystemsRAC Xi TRAY,TRITON 10-03242026-02-25

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