SKYTRON LLC

Address:5085 Corporate Exchange Blvd SE,Grand Rapids,MI,49512,US

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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) (10)

Premarket Exempt

No Yes

Clear

I-Series Washers - 10841736100490 Catalog Number : I5-CP

Device Description : I5 Additiol Chemical pump, includes flow meter and liquid level sensor

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100506 Catalog Number : I5-MIS

Device Description : I5 MIS processing Rack with special pressure chamber and connections ports

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100513 Catalog Number : I5-PRCS

Device Description : I5 Printer clean side, includes mounting panel and cables

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100520 Catalog Number : I5-PRS

Device Description : I5 Rack for processing rigid instrument containers

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100537 Catalog Number : I5-PRSS

Device Description : I5 Printer soiled side, includes mounting panel and cables

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100544 Catalog Number : I5-PT

Device Description : I5 Washer Disinfector w/ dual automated doors 35.5"W x 33"D x 79"H, hot, cold an I5 Washer Disinfector w/ dual automated doors 35.5"W x 33"D x 79"H, hot, cold and fil rinse water connection, 2 chemical pumps, integrated dryer, drain cool down, 4 level rack, Steam, 208V

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100551 Catalog Number : I5-PT-E

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100568 Catalog Number : I5-PT-SE

Device Description : I5 Washer Disinfector w/ dual automated doors 35.5"W x 33"D x 79"H, hot, cold an I5 Washer Disinfector w/ dual automated doors 35.5"W x 33"D x 79"H, hot, cold and fil rinse water, 2 chemical pumps, integrated dryer, drain cool down, 4 level rack, Selectable Steam/Electric, 208V

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100575 Catalog Number : I5-RIB

Device Description : I5 Insert to process large basin & bowls (requires Universal rack I5-2LR).

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100582 Catalog Number : I5-RIKB

Device Description : I5 Insert to process up to 30 kidney bowls (requires Universal rack I5-2LR).

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

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