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) (5) Sterilizer, steam (FLE) (5)

Premarket Exempt

No Yes

Clear

I-Series Washers - 10841736100377 Catalog Number : I5-3LR

Device Description : I5 Three level processing rack, with 2 rotating arms, holds 6 trays up to 19" x 10" x 5.9"

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100384 Catalog Number : I5-4LR

Device Description : I5 Four level processing rack, with 3 rotating arms, holds 8 trays up to 19" x 10" x 4.75"

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

Integrity Sterilizers - 10841736100414 Catalog Number : 215-CR

Device Description : Integrity 215 Loading and Unloading Stainless Steel Transport Cart with Docking Mechanism

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

Integrity Sterilizers - 10841736100421 Catalog Number : 215-LC

Device Description : Integrity 215 Stainless Steel Sterilization Carriage, Two Shelves, Maximum Load Integrity 215 Stainless Steel Sterilization Carriage, Two Shelves, Maximum Load 6 trays (25 lbs. per tray)

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

Integrity Sterilizers - 10841736100438 Catalog Number : 215-LC-CONV

Device Description : Integrity 215 Loading Cart Conversion Rail System

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

Integrity Sterilizers - 10841736100445 Catalog Number : 270-CR

Device Description : Integrity 270 Stainless Steel Sterilization Carriage, Four Shelves, Maximum Load Integrity 270 Stainless Steel Sterilization Carriage, Four Shelves, Maximum Load 16 trays (25 lbs. per tray)

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

Integrity Sterilizers - 10841736100452 Catalog Number : 270-LC

Device Description : Integrity 270 Loading and Unloading Stainless Steel Transport Cart with Docking Mechanism

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100469 Catalog Number : I5-5LR

Device Description : Five level processing rack, with 4 rotating arms, holds 10 trays up to 19" x 10" x 2"

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100476 Catalog Number : I5-APR

Device Description : I5 Anesthesia processing rack

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

I-Series Washers - 10841736100483 Catalog Number : I5-CON

Device Description : I5 Exhaust Condenser (when no vent connection is available)

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

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