FDA.reportPublic FDA data

InnoWave

Primary DI
00724995152727
Brand
InnoWave
Company
MEDISAFE UK LIMITED
Model
IWULTRAPL
Catalog number
IWULTRAPL
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
00724995152727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995152727007249951527277249951527270724995152727

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
00724995152734InnoWaveIWULTRAIWULTRA2021-03-31
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