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) (7) Cleaner, ultrasonic, medical instrument (FLG) (3)

Premarket Exempt

Yes

Clear

InnoWave - 00724995152956 Catalog Number : IW1038

Device Description : The InnoWave PCF XI Basket and Instrument Tubing is used with the The InnoWave P The InnoWave PCF XI 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

InnoWave - 00724995168681 Catalog Number : IW523036NPR

Device Description : The InnoWave Unity Ultrasonic Irrigator is a freestanding ultrasonic cleaner tha The InnoWave Unity Ultrasonic Irrigator is a freestanding ultrasonic cleaner that gives you powerful performance with exceptional ease of use to meet the growing demands of your facility.

Device Class : 1

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

InnoWave - 00724995168698 Catalog Number : IW523046NPR

Device Description : The InnoWave Unity Ultrasonic Irrigator is a freestanding ultrasonic cleaner th The InnoWave Unity Ultrasonic Irrigator is a freestanding ultrasonic cleaner that gives you powerful performance with exceptional ease of use to meet the growing demands of your facility.

Device Class : 1

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

InnoWave - 00724995193737 Catalog Number : IW523546NPR

Device Description : The InnoWave Unity 20 Ultrasonic Irrigator is designed to process up to 16 lumen The InnoWave Unity 20 Ultrasonic Irrigator is designed to process up to 16 lumened devices, or up to 35 lbs. per cycle of non-lumened devices

Device Class : 1

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 1

NA - 05060247261973 Catalog Number : MED11132

Device Description : The Sonic Irrigator PCF Washer Disinfector uses a combination of ultrasonic tech The Sonic Irrigator PCF Washer Disinfector uses a combination of ultrasonic technology and controlled irrigation.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

NA - 05060247262000 Catalog Number : MED11180USA

Device Description : The PCF Pro Washer Disinfector Sonic Irrigation System will clean and thermally The PCF Pro Washer Disinfector Sonic Irrigation System will clean and thermally disinfect 60 lumen robotic instruments in a single cycle.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

NA - 05060247262031 Catalog Number : MED1406

Device Description : The Niagara Sonic Irrigatior PCF Washer Disinfector has a built in ultrasonic ch The Niagara Sonic Irrigatior PCF Washer Disinfector has a built in ultrasonic chamber for Sonic Irrigation cleaning of 48 lumen OR 20 da Vinci instruments.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

NA - 05060247262079 Catalog Number : MED1427

Device Description : The Niagara MED1427 4-Level Carriers have spray arms that simultaneously counter The Niagara MED1427 4-Level Carriers have spray arms that simultaneously counter rotate to provide maximum turbulent wash efficiency.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

NA - 05060247262086 Catalog Number : MED1437

Device Description : The Niagara MED1437 3-5 Level Carriers, multi-use carriers, allows the removal o The Niagara MED1437 3-5 Level Carriers, multi-use carriers, allows the removal of shelves which turns a 5 Level carrier into a 3 Level carrier allowing for the reprocessing of instrument loads of increased height. It also has simultaneous counter rotating spray arms to maximize cleaning efficiency.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

NA - 05060247262093 Catalog Number : MED1450

Device Description : The Niagara MED1450 Container Carrier has simultaneous counter rotation of spinn The Niagara MED1450 Container Carrier has simultaneous counter rotation of spinners to maximize cleaning efficiency.

Device Class : 2

Duns Number: 505942961

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

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