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

TABLE, OPERATING-ROOM, AC-POWERED (FQO) (7) Light, surgical, ceiling mounted (FSY) (4) Disinfector, medical devices (MEC) (3)

Premarket Exempt

No Yes

Clear

I-Series Washers - 10841736100605 Catalog Number : I5-S

Device Description : I5 Washer Disinfector w/ single automated door 35.5"W x 33"D x 79"H, hot, cold a I5 Washer Disinfector w/ single automated door 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 - 10841736100612 Catalog Number : I5-S-E

Device Description : I5 Washer Disinfector w/ single automated door 35.5"W x 33"D x 79"H, hot, cold I5 Washer Disinfector w/ single automated door 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, Electric, 208V

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100629 Catalog Number : I5-S-SE

Device Description : I5 Washer Disinfector w/ single automated door 35.5"W x 33"D x 79"H, hot, cold a I5 Washer Disinfector w/ single automated door 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

Ergon Boom Series - 10841736100636 Catalog Number : E2 110 Series

Device Description : Lightweight Central Mount with optional surgical lighting.

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO, FSY

Prescription Use : Yes

Device Count : 1

Ergon Boom Series - 10841736100643 Catalog Number : E2 120 Series

Device Description : Lightweight Central Tandem Mount with optional surgical lighting.

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FSY, FQO

Prescription Use : Yes

Device Count : 1

Ergon Boom Series - 10841736100650 Catalog Number : E2 200 Series

Device Description : Q Dual Radial Arm Set

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

Ergon Boom Series - 10841736100667 Catalog Number : E2 300 Series

Device Description : Dual Radial Arm Set

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

Ergon Boom Series - 10841736100674 Catalog Number : E2 310 Series

Device Description : Central Mount with optional surgical lighting.

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FSY, FQO

Prescription Use : Yes

Device Count : 1

Ergon Boom Series - 10841736100681 Catalog Number : E2 320 Series

Device Description : Central Tandem Mount with Lightweight Arm with optional surgical lighting.

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FSY, FQO

Prescription Use : Yes

Device Count : 1

Ergon Boom Series - 10841736100698 Catalog Number : E2 330 Series

Device Description : Tandem Mount

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

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