FDA.reportPublic FDA data

InnoWave

Primary DI
00724995152710
Brand
InnoWave
Company
MEDISAFE UK LIMITED
Model
PCF
Catalog number
IWPCF
Device description
The InnoWave PCF Sonic Irrigator is a High-Pressure, Ultrasonic, Flushing Washer Disinfector for the medical market. It is intended to provide ultrasonic cleaning and low-level thermal disinfection of surgical instruments, including complex lumen-cannulated devices, such as robotic surgical instruments.
Published
2017-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MECDisinfector, medical devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MECDisinfector, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995152710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995152710007249951527107249951527100724995152710

GMDN Terms#

Term, Definition table
TermDefinition
Instrument chemical/thermal disinfectorAn electrically-powered unit intended to be used for both chemical and thermal disinfection of probes, surgical instruments, and/or endoscopes, and their accessories. It may include washing features and may have built-in features to circulate cleaning and disinfectant solutions through a device lumen; some types may also have built-in drying features. It is not intended for device sterilization.

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999info@medisafeinternational.com

Regulatory Flags#

DUNS number
505942961
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060247261973NASonic Irrigator PCFMED111322016-09-16
05060247262000NAPCF PROMED11180USA2016-09-16
00724995152741InnoWaveProIWPRO602017-02-21
00724995152819NAIW1008IW10082017-02-21
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
05060247265179NiagaraMP21852IW10492021-03-18
00724995152727InnoWaveIWULTRAPLIWULTRAPL2021-03-31
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
08051520024108SteelcoSTEELCO SPAMEC2026-05-26
08051520022876SteelcoSTEELCO SPAMEC2026-04-17
08051520022852SteelcoSTEELCO SPAMEC2026-03-27
08051520022869SteelcoSTEELCO SPAMEC2026-02-04
04002516952589SteelcoMiele & Cie. KGMEC2026-01-04
04002516952749SteelcoMiele & Cie. KGMEC2026-01-04
04002516952848SteelcoMiele & Cie. KGMEC2026-01-04
04002516952947SteelcoMiele & Cie. KGMEC2026-01-04
08051520021176SteelcoSTEELCO SPAMEC2025-10-28
08051520021770SteelcoSTEELCO SPAMEC2025-09-24
08051520021763SteelcoSTEELCO SPAMEC2025-09-16
08051520021473SteelcoSTEELCO SPAMEC2025-07-24
08051520021480SteelcoSTEELCO SPAMEC2025-07-24
07640397421250HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
07640397421267HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
07640397421274HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
07640397421281HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
04002516883838MieleMiele & Cie. KGMEC2025-07-01
04002516883845MieleMiele & Cie. KGMEC2025-07-01
04002516884781MieleMiele & Cie. KGMEC2025-07-01
04002516884927MieleMiele & Cie. KGMEC2025-07-01
04002516884934MieleMiele & Cie. KGMEC2025-07-01
08051520020957SteelcoSTEELCO SPAMEC2025-06-30
08051520021350SteelcoSTEELCO SPAMEC2025-06-18
08051520021190SteelcoSTEELCO SPAMEC2025-05-22
08051520021169SteelcoSTEELCO SPAMEC2025-05-08
08051520020940SteelcoSTEELCO SPAMEC2025-05-05
08051520020797SteelcoSTEELCO SPAMEC2025-04-10
08051520018879SteelcoSTEELCO SPAMEC2024-09-12
08051520018589SteelcoSTEELCO SPAMEC2024-08-07