MEDISAFE UK LIMITED

Address:Unit 7 & 8, Stortford Hall Industrial Park, Dunmow Road,Bishops Stortford Hertfordshire,GB

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Disinfector, medical devices (MEC) (6) Cleaner, ultrasonic, medical instrument (FLG) (4)

Premarket Exempt

Yes

Clear

InnoWave - 00724995152710 Catalog Number : IWPCF

Device Description : The InnoWave PCF Sonic Irrigator is a High-Pressure, Ultrasonic, Flushing Washer 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.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

InnoWave - 00724995152727 Catalog Number : IWULTRAPL

Device Description : The InnoWave Ultra + Sonic Irrigator tabletop is designed to thoroughly clean (r The InnoWave Ultra + Sonic Irrigator tabletop is designed to thoroughly clean (remove tissue, blood and other contaminants) from a variety of reusable surgical instruments.

Device Class : 1

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

InnoWave - 00724995152734 Catalog Number : IWULTRA

Device Description : The InnoWave Ultra Sonic Irrigator tabletop is designed to thoroughly clean (rem The InnoWave Ultra Sonic Irrigator tabletop is designed to thoroughly clean (remove tissue, blood and other contaminants) from a variety of reusable surgical instruments.

Device Class : 1

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

InnoWave - 00724995152741 Catalog Number : IWPRO60

Device Description : The InnoWave Pro Sonic Irrigator is a High-Pressure, Ultrasonic, Flushing Washer The InnoWave Pro 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.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

InnoWave - 00724995152758 Catalog Number : IWECO2

Device Description : The InnoWave Eco Ultrasonic Cleaner (2.6 GAL) s designed to clean small surgical The InnoWave Eco Ultrasonic Cleaner (2.6 GAL) s designed to clean small surgical instruments with sonic cavitation technology when space is limited in your facility.

Device Class : 1

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

InnoWave - 00724995152765 Catalog Number : IWECO5

Device Description : The InnoWave Eco Ultrasonic Cleaner (5.3 GAL) s designed to clean small surgical The InnoWave Eco Ultrasonic Cleaner (5.3 GAL) s designed to clean small surgical instruments with sonic cavitation technology when space is limited in your facility.

Device Class : 1

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

N/A - 00724995152802 Catalog Number : IW1006

Device Description : The InnoWave Ortho Basket Drop plus Lock for the InnoWave PCF Sonic Irrigator.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

N/A - 00724995152819 Catalog Number : IW1008

Device Description : The InnoWave Standard Basket Drop plus Lock for InnoWave PCF Sonic Irrigator.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

InnoWave - 00724995152826 Catalog Number : IW1010

Device Description : The Standard Basket for SI SA is used with the Medisafe SISA.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

InnoWave - 00724995152949 Catalog Number : IW1037

Device Description : The InnoWave PCF SI Basket and Instrument Tubing is used with the The InnoWave P The InnoWave PCF SI Basket and Instrument Tubing is used with the The InnoWave PCF Sonic Irrigator.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

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