FDA.reportPublic FDA data

InnoWave

Primary DI
00724995152734
Brand
InnoWave
Company
MEDISAFE UK LIMITED
Model
IWULTRA
Catalog number
IWULTRA
Device description
The InnoWave Ultra Sonic Irrigator tabletop is designed to thoroughly clean (remove tissue, blood and other contaminants) from a variety of reusable surgical instruments.
Published
2021-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00724995152734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995152734007249951527347249951527340724995152734

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
+1(999)999-9999info@medisafeinternational.com

Regulatory Flags#

DUNS number
505942961
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995152819NAIW1008IW10082017-02-21
05060247261973NASonic Irrigator PCFMED111322016-09-16
05060247262000NAPCF PROMED11180USA2016-09-16
05060247262093NANiagara MED1450MED14502016-09-20
05060247262116NANiagara MED1451MED14512016-09-20
15060247261871Distal Tip SoakerDistal DuckM204132021-03-31
15060247263318Duck BagDuck BagM203502021-03-31
15060247263325Duck BagDuck BagM203582021-03-31
15060247263332Duck BagDuck BagM203592021-03-31
05060247263199Distal DuckDistal DuckM204002021-03-31
00724995152710InnoWavePCFIWPCF2017-02-21
00724995152741InnoWaveProIWPRO602017-02-21
05060247265179NiagaraMP21852IW10492021-03-18
00724995152727InnoWaveIWULTRAPLIWULTRAPL2021-03-31
00724995152758InnoWaveEcoIWECO22021-03-31
00724995152765InnoWaveEcoIWECO52021-03-31
00724995168681InnoWaveUnityIW523036NPR2021-03-31
00724995168698InnoWaveUnityIW523046NPR2021-03-31
00724995193737InnoWaveUnityIW523546NPR2021-03-31
05060247265193NiagaraMP21854IW10702021-03-18

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