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) (7) Light, surgical, accessories (FTA) (1) Light, surgical, ceiling mounted (FSY) (1) Light, surgical, floor standing (FSS) (1) Sterilizer, steam (FLE) (1)

Premarket Exempt

No Yes

Clear

Integrity Sterilizers - 10841736100131 Catalog Number : INTEGRITY 270VP

Device Description : Integrity 270 Vacuum/Gravity Steam Sterilizer, 26.5"W x 37.5"H x 53"D, Power Doo Integrity 270 Vacuum/Gravity Steam Sterilizer, 26.5"W x 37.5"H x 53"D, Power Door Lock, House Steam, Vacuum Pump

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

Stellar Surgical Light Series - 10841736100148 Catalog Number :

Device Description : LED Surgical Light with center focus

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FSY, FSS

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100155 Catalog Number : I3-CP

Device Description : I3 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

Center Focus Handle - 10841736100278 Catalog Number : B1-710-49-C

Device Description : Center Focus Handle with Intensity Control for Aurora II, Aurora 3 and Aurora Four Lights

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FTA

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100308 Catalog Number : I5-TC

Device Description : I5 Transport Cart for processing racks includes docking device for washer

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100315 Catalog Number : I5-TCD

Device Description : I5 Transport Cart for processing racks includes docking device for cart and washer

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100339 Catalog Number : I3-DCD

Device Description : I3 Drain cool down; reduces the discharged temperature of the water to acceptabl I3 Drain cool down; reduces the discharged temperature of the water to acceptable code requirements

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100346 Catalog Number : I3-MIS

Device Description : I3 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 - 10841736100353 Catalog Number : I3-PR

Device Description : I3 Service door with Printer; 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 - 10841736100360 Catalog Number : I5-2LR

Device Description : I5 Universal two level processing rack, with 1 rotating spray arm.

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

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